In August 2001, biopharmaceutical
company BioPort faced imminent disaster. A series of company scandals,
controversial federal bail-outs and severe, adverse health reactions among U.S.
troops were causing both Congress and the Pentagon to reconsider its
multi-million dollar contract to provide the military with an anthrax vaccine.
Formed for the sole purpose of
acquiring a publicly-owned company in Michigan that held the exclusive license
to manufacture the only FDA-approved anthrax vaccine in the United States,
BioPort sought to quickly expand the size and scope of its contracts with the
U.S. military. This strategy was made possible thanks to the former head of the
Joints Chiefs of Staff, Adm. William Crowe, who would prove highly instrumental
in the rise of BioPort’s vaccine monopoly and its subsequent, aggressive hiring
of former government officials as lobbyists.
Yet, soon after scoring these
multi-million dollar contracts and securing a monopoly on anthrax vaccines,
BioPort would claim that they were flailing financially and would subsequently
be bailed out to the tune of $24 million at the Pentagon’s request, which cited
“national security concerns” as justification.
However, Pentagon auditors had
found that much of the money awarded to BioPort was unaccounted for and the money
they were able to trace had failed to go towards renovating their vaccine
production facility, which had lost its license until numerous sanitary
problems (sanitary and otherwise) were fixed. Meanwhile, scores of soldiers who
had suffered ill health effects from BioPort’s anthrax vaccine, some disabled
for life, began speaking out, bringing BioPort’s most critical product and
chief source of income under unwanted scrutiny.
While BioPort seemingly faced
imminent ruin from these and other scandals in August 2001, the 2001 anthrax
attacks that followed a month later came at just the right time for the
company, as demand for their anthrax vaccine soon skyrocketed, resulting in new
lucrative government contracts. Their license was also quickly renewed thanks to
intervention from the Department of Health and Human Services (HHS) despite
many of the problems with its production facility persisting.
Though they were conveniently
rescued by the unfortunate events of 2001, BioPort would soon lobby for larger
contracts than ever before, calling for a massive increase in government
purchases of their controversial anthrax vaccine. Riding the fear caused by the
2001 anthrax attacks, they pushed for the government to stockpile anthrax
vaccines, not just for the military, but for civilians, postal workers, police
and many more who could potentially be put in harm’s way were the anthrax
attacks to repeat themselves.
One of their biggest proponents
of expanding BioPort’s contracts was working for HHS at the time — Jerome Hauer,
a man who not only had foreknowledge of
the anthrax attacks, but had also participated in the Dark Winter simulation
that would also predict those same attacks just months prior. Hauer would,
months later, be appointed to a newly created position at HHS, one which
oversaw the new biodefense stockpile from which BioPort would be a major
beneficiary.
BioPort would be then renamed
and repackaged as Emergent Biosolutions in 2004. It would then hire even more
well-connected lobbyists and add several big names from government and the
private sector to its board. One of these “big names” was none other than
Jerome Hauer, who was added to Emergent’s board soon after leaving HHS.
Hauer still remains a company
director and sits on three of its corporate governance
committees.
Not only did Emergent
Biosolutions profit from national anthrax fears, they would also cash in on
subsequent pandemic panics and later receive substantial backing from the Bill
Gates-backed Coalition for Epidemic Preparedness Innovations (CEPI). They would
then turn their attention to the still-raging opioid addiction and overdose
crisis by buying rights to the only drug approved for treating opioid overdoses
at the scene while also suing any and all generic producers of this crucial,
life-saving treatment.
Given its history, it should
come as little surprise that Emergent Biosolutions is now set to profit from
the Coronavirus (Covid-19) crisis. They are particularly well-suited to make
record profits off of Covid-19, as they are backing not one, but two, vaccine
candidates as well as an experimental blood plasma treatment already approved
for trials in New York state, thanks in part to Jerome Hauer’s old boss, New York
governor Andrew Cuomo. As noted in a previous article for The Last American Vagabond,the other main companies
developing Covid-19 vaccines in the U.S. are strategic partners of the
controversial Pentagon research agency DARPA, which has become increasingly aligned with
HHS in recent years thanks to another Dark Winter
participant, Robert Kadlec.
In this second installment of
the series “Engineering
Contagion: Amerithrax, Coronavirus and the Rise of the Biotech-Industrial
Complex,”
Emergent Biosolution’s rise to prominence, made possible through acts of
blatant corruption and the public-private revolving door, will be explored. The
clear nexus between Big Pharma, Government and University-affiliated
“Biosecurity Centers” offers a startling look into the Biotech-Industrial
Complex that has long dominated U.S. biodefense policy and is now guiding much
of the U.S. government’s response to the Coronavirus crisis.
A BIO THREAT IS BORN
For half a century, Vladimir
Pasechnik had been a model Soviet citizen, with his scientific prowess in the
field of bioweapons earning him an honorary rank of general. However, having
been granted such a title didn’t seem to inspire much loyalty when he made a
call to the British embassy from a phone booth in France in 1989. The famed
microbiologist subsequently defected to England, a decision that preceded the
fall of the Berlin Wall by a matter of months. Yet, few could have provided a
more riveting view behind the Iron Curtain than Pasechnik, who regaled
Whitehall with shocking tales of monstrous pathogens engineered as part of the
Biopreparat, communist Russia’s top secret biological weapons program.
Pasechnik’s MI6 handler,
Christopher Davis, shared all of the intelligence gathered with his
counterparts in the United States, including claims that Biopreparat programs
had developed antibiotic-resistant strains of anthrax, tularemia and botulinum
toxin. Ancient diseases like the plague had also been modified, according to Davis.
When the stories ran out, Pasechnik was given a job at Britain’s own biodefense
facilities at Porton Down,
where he would remain for another decade before branching out and founding his
own biotech firm.
The Western geopolitical
establishment, however, wasted no time in cementing a new narrative of
imminent, worldwide bioweapons threats following the collapse of the Soviet
Union. Gorbachev’s resignation in 1991 abruptly crashed the Cold War rhetoric
market in the West and the massive military-industrial complex that had
profited from those tensions remained revved up, yet lacking a boogeyman.
Pasechnik was just one of
several Biopreparat alumni who had defected to Western countries, with another
well-known example being Ken Alibek (born Kanatjan Alibekov), who defected to
the US as opposed to the UK. Many of Alibek’s sensational claims and dire
warnings regarding the Soviet bioweapons program in the 1990s would later be proven to be
imaginative falsehoods. Despite this, Alibek retained influence
in the biotechnology industry and Washington, where the ability to sell fear is
often a sought-after trait.
Pasechnik, however, wasn’t so lucky,
dying of a suspected heart attack in November 2001. He was one of 11 of
the world’s top microbiologists to die under mysterious circumstances from
November 2001 to March 2002.
In light of the claims made by
Pasechnik, Alibek and others in the 1990s, a relatively small group of
well-connected individuals — many of whom would later participate in the June
2001 Dark Winter simulation —
asserted that Biopreparat presented an enduring threat, hypothesizing that
defectors from the program might not turn to the West, but instead to rival
regimes like Saddam Hussein’s Iraq.
Anthrax was quickly deemed to
be one of the top threats by these bioweapons doomsayers and then, just months
after the Soviet Union’s collapse, the U.S. Department of Defense issued a
competitive bid solicitation for the production of 6.3 million doses of the
anthrax vaccine. Its previous contract, only a year before, had called for
merely 700,000 doses by comparison.
SOURCING PROBLEMS
The Michigan Biologic Products
Institute (MBPI) had been founded in 1926 by the State to serve the vaccination
needs of its largely rural population, many of whom worked on farms and
required inoculation against naturally occurring anthrax spores and rabies. By
the 1980s, the Institute stood alone as the only anthrax vaccine manufacturer
in the U.S. after 1970s-era regulations had driven most private vaccine
manufacturers out of business. MBPI’s anthrax vaccine was known as Anthrax
Vaccine Adsorbed (AVA) or BioThrax.
Aligning himself with policy recommendations issued
by the Mackinac Center for Public Policy – a front for the
controversial Koch brothers, Michigan’s governor, John Engler,
cited the MBPI’s endemic financial losses to justify putting the nation’s only
licensed anthrax vaccine manufacturer up for sale in 1996. However, upon closer
examination, the real reason behind the decision had more to do with a sudden
spike in demand by the lab’s only customer, the US government, and the MBPI’s
inability to meet it.
The Michigan facility required
massive renovations if it was to fulfill the needs of a national security
establishment that had come to reconstitute itself around the threat of weapons
of mass destruction and biowarfare, a threat largely manufactured by the
stories of Soviet defectors. The Pentagon offered to pony up $1.8 million for
the necessary renovations, but there were no takers — at least, none with a US
passport.
That same year, perennial US
defense contractor, Dyncorp, went into business with a shadowy group of biotech
entrepreneurs from across the pond, forming the DynPort Vaccine Company, LLC.,
a combination of DynCorp’s name with that of its UK-based partner, Porton
International, Inc. The latter company’s president, Zsolt Harsanyi, would also
lead DynPort as the British firm began to lay the groundwork for its second
attempt at securing a crucial monopoly within the American biotech space.
GERM MONOPOLY
Porton International had come
into existence as a result of the Thatcherite revolution that balkanized
British public sector assets and distributed them among private interests that
frequently had close and cozy ties with Thatcher-era officials and other UK
politicians. Among these assets was the Centre for Applied Microbiology and
Research (CAMR), a biotechnology arm of the United Kingdom’s infamous Defence
Science and Technology Laboratory, commonly referred to as Porton Down, which
also happened to house the UK’s own anthrax vaccine program.
Porton International began
operations in 1982, when London financier, Wensley Haydon-Baillie, founded the
company to develop a herpes medication invented by Dr. Gordon
Skinner, which had stalled during clinical trials and never actually
entered the market. In 1985, Haydon-Baillie secured exclusive rights to
commercialize drugs developed by the CAMR, a sweetheart deal from the Thatcher
government that drew in large investments from British Telecom and Lloyds Bank,
among others, totaling £76 million. Haydon-Ballie profited handsomely from the
venture, collecting annual dividends of half a million pounds and selling some
of his shares for £24 million in 1986.
In 1989, Porton International
acquired Sera-lab and Hazleton Biologics, Inc., providing it with an established distribution
network. The following year, the company’s bid to outright
purchase the 650-employee CAMR lab, would be accepted by British Health
Secretary, Kenneth Clark, despite opposition from the staff who had voted
against the takeover.
HOUSE OF FUAD
By the time the sale closed,
Haydon-Ballie — once the 50th richest man in England — was on the brink of
being forced out of Porton International over accusations of illicit
enrichment. Around the same time, the anthrax vaccine was set to enter a bull
market and Porton International was now in a prime position to reap the full
benefits.
A year earlier in 1989, Ibrahim
El-Hibri, a Venezuelan citizen who had made a fortune working
for US telecommunications companies, had become a silent partner in Porton
International. His son, Fuad El-Hibri, was made director of Porton Products,
Ltd, a Porton International subsidiary, which was the conduit by which the
El-Hibri family had made a killing selling anthrax vaccines to
Saudi Arabia and other Gulf states at $300 to $500 a dose.
Fuad El-Hibri had previously been an intelligence contractor for Booz Allen
Hamilton and an executive at the Wall Street giant, CitiGroup.
The elder El-Hibri had a knack
for business that ran back decades to the 1970s when he lived in Qatar,
where he befriended the then-head
of US Central Command, Admiral William Crowe. The career
military man kept in touch with El-Hibri through the years and perhaps even
gave him a few business leads at a time when Crowe was also serving on the
board of pharmaceutical behemoth, Pfizer. Crowe would later pick up the phone
in late 1997 (officially at least, but probably well before) to make a
proposition to his old friend.
In 1997, then-US Secretary of
Defense William S. Cohen announced a plan to vaccinate every single member of
the US Armed Forces against anthrax, which ultimately resulted in the
vaccination of approximately 2.4 million troops by 2003. Admiral Crowe, who was
serving as the US ambassador to the UK at the time, quickly contacted El-Hibri
to discuss the US government anthrax vaccine market in light of this new
Pentagon policy.
The only obstacle was getting
his son, Fuad El-Hibri, a U.S. passport so that he could run the business
stateside. To easily and quickly circumvent this issue, the
politically-connected Admiral — with his deep ties to the Pentagon intact
— was made a director of
BioPort and given 10% of company stock, despite not having
put a single penny into the company.
The stage was set to bring
Porton International into the exclusive government contract business in the
United States as BioPort, Inc. As luck would have it, Porton International’s
president, Zsolt Harsanyi, had just received a ten-year DoD contract
worth roughly $322 million through
DynPort Vaccine Company, LLC, and — thanks to Michigan’s governor — the only
licensed anthrax vaccine manufacturing plant in the country was back on the
auction block.
A STEAL AND A SCAM
In September 1998, BioPort
acquired the MBPI facility through a $25 million package of loans, cash and
promises to pay Michigan state more for the company in the future, promises
that were later broken. It was later revealed that El-Hibri and other BioPort
partners had only placed $4.5
million of their own money into this package.
As previously mentioned, the
MBPI plant in Lansing, MI had come with issues and had been closed for
renovations six months prior to its purchase by BioPort. However, the MBPI had
received millions from the Pentagon to fix the issues identified by the Food and
Drug Administration (FDA) that had affected the vaccine’s “stability, potency
and purity.”
Along with these issues,
BioPort had also inherited military
contracts worth nearly $8 million for anthrax vaccines. They quickly secured
another contract for the same totaling more than $45
million, with an additional $16 million in cash for immediate
renovations — a sizable deal likely due to BioPort’s aggressive hiring of
former Pentagon and federal officials as lobbyists in addition to Crowe’s own
deep ties to the Pentagon.
Despite the massive influx of
cash, BioPort did not spend the money on renovating the plant and its sanitary
issues, likely due to the fact that the deal required the Pentagon to buy
anthrax vaccines from BioPort even if the plant and the vaccines it had
produced lacked a FDA license.
With the Pentagon obligated to
buy the vaccine, regardless of whether it was usable, BioPort spent millions
renovating its executives’ offices, as opposed to the vaccine factory, and
millions more on bonuses for “senior management.” Pentagon auditors would later find that
still millions more had gone “missing” and BioPort’s staff were unaware of the
cost of producing a single dose of the vaccine.
Despite the clear mismanagement
and corruption, BioPort demanded to be bailed out by the Pentagon, requesting
even more money to replace what they had lost and squandered. Though Pentagon
auditors argued that the company should be abandoned, top military officials
cited “national security” and awarded BioPort with an additional $24.1 million.
They also upped the price to be paid for each dose of the anthrax vaccine,
which only has a shelf life of 3 years, from $4.36 to $10.64.
Congress would hold hearings on
the bail-out, hearings that went nowhere. During one of those hearings,
then-Rep. Walter Jones (R-NC) would state the following:
“The message seems clear: If a
company wants to make millions without providing a product or service, enter
into a sole-source contract with the Department of Defense to produce vaccines.
BioPort appears to have the government over a barrel.”
Unsurprisingly, this would only
be the first of BioPort’s federal bail-outs.
FORTUNE FAVORS THE CORRUPT
With BioPort well aware of its
powerful position early on, it dragged its feet in getting its factory
relicensed and up to federal standards. Meanwhile, due to the nature of the
contract, the Pentagon kept buying up large amounts of vaccines that were
unusable, and arguably unsafe, while also still paying BioPort for storage of
the useless product.
During this time, anthrax
vaccine doses made prior to these renovations were being used on U.S. troops,
with many of those soldiers claiming that the vaccine produced in the troubled
facility had given them permanent headaches, joint pain, loss of memory and
other, more severe symptoms. Some were even disabled for life. Congress again
held hearings, but they were stuffed with BioPort employees posing as “experts”
as well as others who supported the Pentagon’s contract with the company.
However, in 2000, the Pentagon
did finally lose patience and demanded that BioPort stop making BioThrax.
BioPort obliged, but kept receiving government money to keep it afloat. By
August 2001, the Lansing facility was still unlicensed and BioPort was still
demanding government money to keep it from going out of business. That month,
Congress and the Pentagon began to publicly discuss abandoning
BioPort. The Pentagon began preparing a report, due to be released in
September 2001, that would detail a plan for letting BioPort go.
Fortunately for BioPort but
unfortunately for the nation, the events of September 11, 2001 and the
subsequent anthrax attacks led to major increases in fear and panic that
anthrax attacks could become a recurrent nightmare for the American public and
that radical terror groups and rival nations sought to target, not just
American soldiers with anthrax, but also the country’s civilians.
The ensuing panic led the
Department of Health and Human Services (HHS) to intervene, returning BioPort
its license in January 2002 despite persisting safety concerns at its vaccine
production facility. BioPort was not content to merely see its past contracts
with the Pentagon restored, however, as it began lobbying heavily for new
contracts for anthrax vaccines intended for American civilians, postal workers
and others. They would get them, largely thanks to HHS’ then-counter-terrorism
adviser and soon to be HHS’ newest Assistant Secretary — Jerome Hauer.
JEROME HAUER’S CURIOUS PAST
As BioPort secured its control
over the only licensed anthrax vaccine producer in the country in 1998, New
York’s emergency crisis manager and bioterrorism expert, Jerome Hauer, was busy
working and making doomsday contingency plans from his “bunker” on the 23rd
floor of World Trade Center Building 7.
Put on the job by then-NY Mayor
Rudy Giuliani in 1996, Hauer had previously managed worldwide emergency
response for technology giant IBM. He also was an adviser to the Justice
Department, had briefed President Clinton on bioterror threats and was known to
“consult regularly with
Scotland Yard and the Israeli military.” It was reportedly
Hauer’s idea to locate the city’s emergency management office at Building 7,
even though placing it there was considered controversial at the time due to
the 1993 World Trade Center bombings, bombings that were later revealed to
have disturbing links to
the FBI.
In 1999, the New York Times would
describe Hauer’s job as “sitting around all day thinking up
horrifying ways for things to be destroyed and people to die.” It would also
note that Hauer described his expertise regarding specific emergency situations
as follows: “helicopter crash, subway fire, water main break, ice storm, heat
wave, blackout, building collapse, building collapse, building collapse.” His
obsession with building collapses even led him to house “trophies” of the
building collapses he had overseen and responded to. How odd then that Hauer’s
multi-million dollar “bunker” itself would later fall victim to building
collapse, falling into its own footprint in 7 seconds on September 11, 2001.
That fateful day, Hauer was no
longer with NY’s Office of Emergency Management, having left in February 2000.
However, in 2001, Hauer still worked at the World Trade center complex, running
security for the buildings as managing director of Kroll Inc. Informally known
as the “CIA of Wall Street”, Kroll was alleged to be an actual front for the
CIA by French intelligence agencies, according to the Washington Post.
Though it claimed to be mainly involved in corporate security and
investigations, it also frequently investigated targets
of Washington foreign policy, including Saddam Hussein. Kroll was also the
company tapped to “reorganize” Enron in 2002.
Though Hauer should have been
at his office at the World Trade Center on the morning of September 11, 2001,
he did not show up for work that day and instead made TV media appearances,
where he claimed that Osama bin Laden had been responsible for the attacks just
hours after the towers collapsed in an interview with Dan Rather.
Yet, not all Kroll employees
were as lucky as Hauer. John O’Neil had just begun working for Kroll and was at
the World Trade Center that day, dying in the attacks. O’Neil had previously
worked with the FBI and was the country’s top expert on Osama bin Laden and his
activities. He had resigned in mid-2001 after his investigations into bin Laden
were repeatedly blocked by his superiors, something that happened to numerous federal
investigators prior to 9/11, and was subsequently offered a
job at Kroll by none other than Jerome Hauer himself.
Also on the day of 9/11, Hauer
had told top
Bush administration officials to start taking the antibiotic Cipro to prevent
infection via anthrax and Hauer would subsequently make public hints via mass
media that foreign terrorists were working with Saddam Hussein to unleash an
anthrax attack on the American public. All of this took place well before the
first anthrax attack victim, photojournalist Robert Stevens, would even show
symptoms.
Hauer had prepared for a
scenario just like the anthrax attacks as part of the Dark Winter biowarfare
simulation, which occurred just months prior and at a time when Hauer was a member of
the Johns Hopkins Working Group on Civilian BioDefense, part of what is now the
Johns Hopkins Center for Health Security, then led by Dark
Winter co-author Tara O’Toole. The Dark Winter exercise and its current
relevance are discussed in detail in Part I of
this series.
Also of note is the fact that,
while working for Kroll Inc. Hauer was also working for the
Scientific Applications International Corporation (SAIC), a defense and
intelligence contractor. There he became a co-worker of Stephen Hatfill, who
Hauer had actually met years
prior. At SAIC, Hatfill worked on developing protocols for
handling “anthrax hoax letters,” a phenomenon present in Dark Winter and later
during the actual 2001 anthrax attacks. Hatfill would later be accused of
having committed those very attacks, but was later cleared of suspicion,
winning a hefty multi-million dollar settlement from the government.
In addition to his work for
SAIC and Kroll as the events of September 11, 2001 transpired, Hauer was also a national
security adviser to then-head of the Department of Health
and Human Services (HHS), Tommy Thompson. Hauer closely advised Thompson during
the 2001 anthrax attacks and after, helping to shape HHS response and
subsequent biodefense policy, which focused heavily on BioPort’s anthrax
vaccine.
HAUER AND HHS
As the anthrax attacks
unfolded, Hauer advised Secretary Thompson to establish a new office at
HHS, the Office of Public Health Preparedness (OPHP), whose first acting
director was Dr. D.A. Henderson, a former official with the World Health
Organization and the original founder of the
Johns Hopkins Working Group on Civilian Biodefense, which had sponsored Dark
Winter and included Jerome Hauer as well as Dark Winter co-authors Tara O’Toole
and Thomas Inglesby. In early 2002, Hauer himself would replace Henderson as
head of the newly created OPHP.
In May 2002, Hauer — while
leading OPHP — co-authored a report with
members of the Johns Hopkins Working Group, including O’Toole and Inglesby. In
that paper, published in the prestigious Journal of the American Medical Association (JAMA), Hauer, O’Toole,
Inglesby and their co-authors argued that greater
production and purchase of anthrax vaccine was necessary in light of the 2001
anthrax attacks and that government funding was also needed to research a new
anthrax vaccine. They also asserted that the vaccine did not cause any
significant adverse effects.
Notably, just months prior,
O’Toole and Inglesby had come under scrutiny in
their attempts to link the anthrax attacks to Al Qaeda, several months after
that possibility had been ruled out completely by federal investigators and
other independent scientists.
The paper authored by the Johns
Hopkins Working Group would also come under scrutiny, particularly their
recommendation that the government acquire more BioThrax. This was largely
because the evidence from the attacks showed that antibiotics were much more
effective and less expensive in responding to anthrax attacks, with subsequent studies claiming that calls for
stockpiling more BioThrax “defy medical evidence and expert recommendations”
based on lessons learned during the anthrax attacks.
Then, in June 2002, the Public
Health Security and Bioterrorism Preparedness and Response Act was signed into
law by President Bush, creating the post of
Assistant Secretary for Public Health Emergency Preparedness, which was quickly
filled by Hauer and gave him near-complete power over HHS’ biodefense policy
and all HHS matters related to “national security.”
In July 2002, Hauer and his
deputy William Raub helped push the
Pentagon to restart vaccinating the troops, despite long-standing concerns over
the vaccine’s safety. Per the new immunization program, the number of troops
being vaccinated would “jump,” according to officials. However, the size of
that increase was never made public. In addition, half of the Pentagon’s
BioThrax purchases would be stockpiled for civilian use.
Though Hauer, O’Toole,
Inglesby, the Pentagon and, of course, BioPort, continued to assert that
BioThrax was safe for human use, the Government Accountability Office
(GAO) would release its findings just
months later that showed that the vaccine “caused adverse reactions in most
recipients [85%] and helped prompt many Air Force Reserve and Air National
Guard members to transfer to other units or leave the military between 1998 and
2000.” The Pentagon and HHS rejected the GAO’s conclusions.
Despite rejections from the
Pentagon and HHS, the number of veterans suffering ill effects from BioThrax
continued to mount. Even mainstream sources began to report on claims linking
BioThrax to over 20 deaths and over 4,000 illnesses, 347 of which were deemed
to be “serious.”
As a result, in March 2003, six
military service-members and Defense Department civilian contractors sued the Pentagon, HHS and
the FDA over the mandatory BioThrax vaccination policy, claiming
that the way the vaccine had been administered in the 1990s and in the early
2000s was experimental.
This claim was based on the
fact the FDA had not approved BioThrax for use against aerosol exposure to
anthrax (i.e. anthrax inhalation). However, the Pentagon was using BioThrax to
ostensibly protect soldiers from exposure to aerosol anthrax, which is the form
of anthrax that would be encountered by soldiers in a bioweapon or bioterrorist
scenario. Thus, the Pentagon was injecting soldiers with BioThrax for a use for
which it was not federally approved, rendering its use experimental. Given that
the federal mandating of experimental vaccines is illegal, a federal
judge ruled that the
Pentagon’s mandatory Biothrax vaccination program was illegal in October 2004.
The ruling was a blow to
BioPort, which had reorganized that year and took on the name Emergent
BioSolutions. However, BioPort/Emergent BioSolutions would find relief in 2006,
when the Pentagon decided to resume mandatory anthrax immunizations among U.S.
servicemen soon after the FDA decided to approve BioThrax as a treatment for
anthrax inhalation.
BIOSOLUTION’S BIOSHIELD
Just months before the
Pentagon’s BioThrax vaccine program was deemed illegal, Congress passed the
Project BioShield Act, an act that was largely written by Emergent
BioSolution lobbyists and greatly influenced by Robert
Kadlec, who was then serving as the
Homeland Security Council’s Director of Biodefense. The goal of the act was to
allocate $5 billion to be used to purchase vaccines, including millions of
doses of anthrax vaccine, and stockpile them in the event of a future
bioterrorist attack. Given that these vaccines have a limited shelf life (three
to four years in BioThrax’s case), the stockpile would continually need to be
renewed as its contents gradually expired.
Not long after BioShield was
signed into law, Emergent BioSolutions co-founded a lobby group called
the Alliance for Biosecurity as part of its strategy to easily secure lucrative
BioShield contracts. That lobby group saw Emergent BioSolutions join forces
with the University of Pittsburgh’s Center for Biosecurity, which was created
in 2003 and populated with former members of the Johns Hopkins Institute for
Civilian Biodefense Strategies. At the time, the University of Pittsburgh’s
Center was led byTara
O’Toole.
Though Emergent BioSolutions
had contacts with the key organizations and people in the biodefense-industrial
complex, the Bush administration and the military, BioShield initially didn’t go
as planned for the company. Instead of pumping even more money into the
controversial BioThrax, HHS decided to invest in a new anthrax vaccine that
involved fewer doses and fewer adverse side effects, and thus less controversy.
In November 2004, HHS through
BioShield awarded VaxGen Inc. a
$877.5 million contract to produce a recombinant anthrax vaccine and was the
first contract made via BioShield. In great contrast to Emergent’s past
BioThrax contracts with the government, the VaxGen contract did not provide the
company with government money until the vaccine was approved and subsequently
delivered.
The VaxGen contract greatly
concerned BioPort/Emergent Biosolutions for obvious reasons. In order to avoid
losing their vaccine monopoly, they invested heavily in lobbying and spent $5.29 million on
lobbyists from 2004 to 2007. By comparison, over that same period, VaxGen spent
$720,000 on lobbyists.
One of those lobbyists was Jerome Hauer,
who was also added to Emergent’s
board shortly after leaving HHS. Despite Hauer having supported a new anthrax
vaccine other than BioThrax while he had worked at HHS, Hauer suddenly began to
insist that BioThrax was the solution. He also demanded that his replacement at
HHS, Stewart Simonson, who was ultimately responsible for VaxGen’s BioShield
contract, be stripped of his authority. Other lobbyists hired by Emergent at
the time included two former aides to
then-Vice President Dick Cheney and former aides to influential members of
Congress.
The hiring of Hauer and others
well-connected to the Bush administration and Congress was just part of
Emergent’s aggressive lobbying against the VaxGen contract, as the company also
employed mafia-esque tactics, telling lawmakers and
government officials that U.S. civilians “were at risk of
death without an immediately expanded stockpile of [BioThrax] anthrax vaccine”
and threatening to “stop making the vaccine if the government chose not to buy
its product for the stockpile.”
The war between Emergent
BioSolutions and VaxGen spread to Congressional hearings, where Congressmen who
had received thousands from Emergent’s then-CEO attacked the
VaxGen BioShield contract, with one calling it “highly suspect” and angrily
demanding that HHS explain why it had not purchased more BioThrax. It also
spread to the press, where Emergent lobbyists wrote Op-Eds in
influential newspapers.
Emergent even found unlikely
supporters in “progressive” journalists like Jeremy Scahill, who wrote an article for The
Nation in which he praised Jerome Hauer, framing him as
a champion of public health preparedness who was at odds with Bush-era neocons
(despite his membership in organizations stuffed with those same neocons).
Scahill also strongly criticized Hauer’s successor Stewart Simonson and the
VaxGen contract.
Scahill did not mention in his
report that Hauer was then working as a lobbyist for Emergent BioSolutions or
was a member of its board, despite interviewing him for the piece. Scahill
didn’t even mention Emergent BioSolutions (or its previous name BioPort) once
in the entire article, despite it being VaxGen’s main competitor.
Finally, in 2006, HHS
terminated VaxGen’s contract after the company hit a developmental snag with
its vaccine, declining to offer them the type of lifelines that Emergent
BioSolutions had received on numerous occasions under its previous name
BioPort.
After VaxGen’s contract with
HHS was crushed, Emergent BioSolution’s anthrax vaccine monopoly remained
intact, at least for a time. However, PharmAthene, another biotechnology
company that had co-formed the Alliance for Biosecurity lobby group with
Emergent, soon announced its plans to develop its own recombinant anthrax
vaccine. This prompted Emergent to end up buying the
essentially bankrupt VaxGen and acquiring the very VaxGen anthrax vaccine it
had spent millions of dollars over several years to discredit.
A few years later, Emergent’s
competitors made inroads with the Pentagon, with the military offering
contracts for the anthrax vaccine developed by PharmAthene and another
manufactured by PaxVax. Emergent aggressively challenged its competitors or bought them out in
order to retain its monopoly, while also developing three new anthrax vaccines (one
of which was the VaxGen vaccine) to satisfy government demand for a new anthrax
vaccine. Only one, dubbed NuThrax, ever made any progress.
NuThrax, a combination of
BioThrax and an adjuvant, would be yet another gold mine for Emergent Biosolutions.
The company received $127 million from
HHS’ Biomedical Advanced Research and Development Authority (BARDA) and the
National Institute of Allergy and Infectious Diseases (NIAID) for early
development. Meanwhile, they began to dramatically scale up their production of
BioThrax with even more grants from
BARDA. Then, in 2016, it received an additional $198
million from HHS for further development of NuThrax as well
as a government promise to purchase up to 50 million doses for the national
biodefense stockpile. That promise was made as part of a contract valued at up
to $1.6 billion and
was also made before NuThrax received approval by the FDA. To date, NuThrax
still remains unapproved by the FDA.
THE A TEAM
It is worth noting that Hauer
was not the only key government official that had aided BioPort and was later
awarded with a position on its board of directors. A few years after Hauer
became a board member of Emergent Biosolutions, the company added Dr. Sue Bailey to
its board in 2007. Bailey had previously served as the Pentagon’s former top
medical official during the late 1990s and played a key role in keeping the
military’s anthrax vaccine program from being derailed from persistent concerns
from veterans about its safety and adverse side effects.
Back in 1999, when Congress had
held its hearings into the anthrax vaccine’s safety following concerns raised
by affected veterans, Bailey was part of a panel of experts, which had included
BioPort’s Admiral William Crowe. In her prepared statement, Bailey began by
underscoring the urgency of the bioterrorist threat, claiming that “at least ten nation states
and two terrorist groups“ possessed biowarfare capabilities and
citing a 1958 study by Johns Hopkins University as proof that anthrax
vaccinations were safe. She concluded by reassuring members of Congress that
they had a “safe and effective vaccine to respond to a well-documented threat.”
Neither of these statements would turn out to be true.
Another expert Dr. Katherine
Zoon, who was then director of the FDA’s Center for Biologics Evaluation,
concurred with Dr. Bailey’s assessment regarding the safety of the anthrax
vaccine in her statement. Zoon, who would subsequently hold key posts at the
National Institute of Allergy and Infectious Diseases (NIAID) and at the
National Institutes of Health (NIH), was also added to Emergent’s
board of directors.
The statements that had been
made by Zoon and Bailey at that hearing were a significant divergence from the
FDA’s own appraisal on the long-term safety of the vaccine, according to testimony by
Kwai-Cheung Chan of the General Accounting Office (GAO). Chan practically
invalidated both Bailey’s and Zoon’s testimony by revealing that the studies
they had cited were carried out on a completely different anthrax vaccine that
was produced by Merck, not Emergent BioSolutions, among other details. Chan’s
testimony made it clear that BioThrax had no safety track record at all. Not
unlike Hauer, Emergent later rewarded Bailey and Zoon for their loyalty to the
private sector as opposed to public health with board positions and lucrative
stock options.
“NEVER LET A GOOD CRISIS GO TO
WASTE”
Though Emergent Biosolutions
has enjoyed its privileged status regarding the anthrax vaccine for over two
decades, it has long since branched out and profiteered from a variety of
pandemic scares, including Ebola and Zika, and
public health crises both globally and domestically. They have also acquired
other vaccine monopolies, including the U.S.’ only licensed smallpox
vaccine through their purchase of Sanofi, which came with a
$425 million government contract and the promise of subsequent multi-year
renewals on that contract for the ever-increasing national biodefense
stockpiles.
Another drug monopoly acquired
by Emergent Biosolutions has allowed them to profit handsomely off of the U.S.’
devastating opioid epidemic.
In 2018, a year when the opioid crisis claimed the lives of nearly 70,000
Americans and was considered the top health crisis facing
the nation, Emergent acquired the
producer of Narcan, the only FDA-approved nasal spray of naloxone, which is
used to treat opioid overdoses at the scene. At the time of acquisition,
Emergent BioSolutions executive Daniel J. Abdun-Nabi referred to U.S. high
schools and colleges as lucrative, “untapped markets”
for Narcan.
Two months after Emergent
completed its acquisition of the Narcan monopoly, HHS began recommending that
doctors co-prescribe the drug alongside opioid painkillers. However, HHS
offered no measures aimed at preventing the over-prescription of opioid
painkillers like fentanyl and has remained silent regarding
efforts to make opioid painkillers a controlled, schedule 1 substance. After
the HHS recommendation regarding Narcan, several states subsequently passed
laws requiring doctors to co-prescribe the nasal spray. Emergent’s sale of
Narcan, which now costs$150
per dose, predictably spiked.
Regarding its Narcan monopoly,
Emergent has long claimed that they are working to keep the drug
affordable and they have even donated Narcan to public
libraries and YMCAs as part of a major public relations
push. However, Emergent’s same-old aggressive tactics still
apply to Narcan, as they have sued any
competitors aiming to market a cheaper, generic version of the drug. In
addition, government promotion of Narcan as opposed to other, longer-term
solutions to opioid addiction, have come under scrutiny, with some arguing that
Narcan actually enables opioid
addiction and may actually be worsening the crisis.
CORNERING THE COVID-19 MARKET
Emergent’s history of
corruption and profiteering has in no way prevented them from cashing in on the
Covid-19 global health crisis. On March 10, Emergent announced a partnership with
Novavax to produce a Covid-19 vaccine, a vaccine also backed by the Bill
Gates-backed Coalition for Epidemic Preparedness Innovations (CEPI). CEPI had
previously partnered with Emergent Biosolutions, giving them over $60 million in
2018. Emergent further expanded its
partnership with NovaVax on March 31.
Just 8 days after partnering
with Novavax, Emergent partnered with yet another producer of a Covid-19
vaccine candidate, VaxArt. Unlike the Emergent-Novavax vaccine, the vaccine
candidate co-produced with VaxArt will be oral and in pill form, “offer[ing]
enormous logistical advantages in the roll-out of a large vaccination
campaign,” according to VaxArt CEO Wouter Latoud.
While backing two of the most
prominent vaccine candidates for Covid-19 gives Emergent an advantage in terms
of profiting from whatever vaccines end up being approved for use by the
government, Emergent’s star has risen during the current Coronavirus crisis
largely thanks to its two experimental blood plasma treatments.
Announced just one day after
their Novavax vaccine partnership, Emergent’s first experimental blood plasma
treatment involves pooling and concentrating blood plasma from recovered
Covid-19 patients, while the second uses plasma taken from horses that have
been injected with parts of the virus. These treatments were slated to begin
clinical trials later this year, but have been greatly aided by HHS’ BARDA,
which falls under the authority of Robert Kadlec. These treatments are now
expected to begin Phase II trials by late summer.
On April 3, BARDA awarded Emergent
Biosolutions $14.5 million for the development of its blood
plasma treatment. Though the sum is smaller than other contracts Emergent has
received from BARDA in the past, the partnership allows Emergent to overcome
its greatest obstacle in developing this product, a massive supply of blood
plasma from recovered Covid-19 patients. Thanks to their partnership with
BARDA, Emergent will gain access to blood donations made by recovered Covid-19
to public blood centers.
Emergent’s Dr. Lisa Saward
confirmed this in a recent interview with TechCrunch,
stating “we are overcoming [the lack of “source material” i.e. blood plasma]
with the help of partnerships like that of the Biomedical Advanced Research and
Development Authority within Health and Human Services, and the National
Institute of Allergy and Infectious Diseases announced earlier this week.”
However, Emergent’s use of
donated plasma to develop its product may prove controversial, since the plasma
donated by recovered Covid-19 patients is currently being used as a treatment
for seriously ill Covid-19 patients. The use of plasma to treat critical
patients began late last month after New York’s state government first authorized
its use in such cases, followed by the FDA’s offer to approve its use for
critical Covid-19 patients nationwide on a case-by-case basis. Yet, thanks to
the BARDA and Emergent partnership, a significant amount of that plasma will
instead go towards helping Emergent corner yet another key market.
https://www.unz.com/wwebb/a-killer-enterprise-how-one-of-big-pharmas-most-corrupt-companies-plans-to-corner-the-covid-19-cure-market/
