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April 10th, 2020 
Awake Goy 
Originally published at The Last American Vagabond
“One of the most politically-connected yet scandal ridden vaccine companies in the United States, with troubling ties to the 2001 anthrax attacks and opioid crisis, is set to profit handsomely from the current Coronavirus crisis.“
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 by Tara 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.
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