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Monkeypox Fears May Rescue Endangered Corporations

By Whitney Webb | Unlimited Hangout | May 20, 2022

In recent days, concern over a global outbreak of monkeypox, a mild disease related to smallpox and chickenpox, has been hyped in the media and health ministries around the world, even prompting an emergency meeting at the World Health Organization (WHO). For some, fears have centered around monkeypox being the potential “next pandemic” after Covid-19. For others, the fear is that monkeypox will be used as the latest excuse to further advance draconian biosecurity policies and global power grabs.

Regardless of how the monkeypox situation plays out, two companies are already cashing in. As concern over monkeypox has risen, so too have the shares of Emergent Biosolutions and SIGA Technologies. Both companies essentially have monopolies in the US market, and other markets as well, on smallpox vaccines and treatments. Their main smallpox-focused products are, conveniently, also used to protect against or treat monkeypox as well. As a result, the shares of Emergent Biosolutions climbed 12% on Thursday, while those of SIGA soared 17.1%.

For these companies, the monkeypox fears are a godsend, specifically for SIGA, which produces a smallpox treatment, known by its brand name TPOXX. It is SIGA’s only product. While some outlets have noted that the rise in the valuation of SIGA Technologies has coincided with recent concerns about monkeypox, essentially no attention has been given to the fact that the company is apparently the only piece of a powerful billionaire’s empire that isn’t currently crumbling.

That billionaire, “corporate raider” Ron Perelman, has deep and controversial ties to the Clinton family and the Democratic party as well as troubling ties to Jeffery Epstein. Aside from his controlling stake in SIGA, Perelman has recently made headlines for rapidly liquidating many of his assets in a desperate bid for cash.

Similarly, Emergent Biosolutions has also been in hot water. The company, which has troubling ties to the 2001 Anthrax attacks, came under fire just under two weeks ago for engaging in a “cover up” over quality control issues relating to their production of Covid-19 vaccines. A Congressional investigation found that quality control concerns at an Emergent-run facility led to more than 400 million doses of Covid-19 vaccines being discarded. The Emergent factory in question had been shut down by the FDA in April 2021. They were allowed to reopen last August before the government terminated the contract. Given that the majority of the company’s business is tied to US government contracts, the loss of this contract, and the accompanying poor publicity, the news that its smallpox vaccine may soon be of international interest is likely seen as a godsend by the company.

Notably, this is the second time in a year that both companies have benefitted from pandemic or bioterror fears propagated by the media. Last November, speculation rose that a re-emergence of the eradicated virus that causes smallpox would soon take place. This first began with Bill Gates’ comments on the prospects of smallpox bioterrorism during a November 4th, 2021 interview and was followed by the November 16th announcement of a CDC/FBI investigation into 15 suspicious vials labeled “smallpox” at a Merck facility in Philadelphia. Now, roughly six months later, the same fears are again paying off for the same two companies.

A Killer Enterprise

Emergent Biosolutions was previously known as BioPort. The company was founded by Fuad el-Hibri, a Lebanese businessman, who leveraged his contacts with powerful US former military officials and politicians, to take control of a flailing Michigan factory. It was the only factory authorized to produce an anthrax vaccine.

The anthrax vaccine was known to have major problems even before BioPort had acquired it, and is believed by many investigators to be one of the main causes of “Gulf War” syndrome. The vaccine itself, originally developed at Fort Detrick, had little to no safety track record at the time it was administered to US troops in the First Gulf War – a problem that was never remedied. However, its chronic safety issues and its clumsy, multi-dose regimen would later prompt BioPort/Emergent Biosolutions to spend years developing a new formulation of its anthrax vaccine.

The creation of BioPort coincided with the Clinton administration’s efforts to mandate the anthrax vaccine for all members of the US Armed Forces. With control over the only source of anthrax vaccine, BioPort was poised to make a killing.

Once the company acquired the Michigan facility, it took large amounts of US government funds, ostensibly to make improvements at the site. However, the company declined to use the funds to make the necessary repairs, instead spending that money on 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, and they were. Meanwhile, the Michigan facility lost its license after a government inspection found numerous safety issues.

However, by August 2001, BioPort stood to lose the Pentagon contracts – its only source of income. The Pentagon began preparing a report, due to be released in September 2001, that would detail a plan for letting BioPort go. Thanks to the September 11, 2001 attack on the Pentagon, that report was never released. Shortly thereafter, the 2001 anthrax attacks began.

Just months before, BioPort had contracted Battelle Memorial Institute to help rescue its flailing vaccine program. The deal gave Battelle “immediate exposure to the vaccine” and it was used in connection with the Pentagon-funded, gain-of-function anthrax program that involved both Ken Alibek and William C. Patrick III, two bioweapons experts with deep ties to the CIA. That program was housed at Battelle’s West Jefferson facility in Ohio. That facility is believed by many investigators to be the source of the anthrax used in the 2001 attacks.

The ensuing panic from the anthrax attacks led the Department of Health and Human Services (HHS) to intervene. They gave BioPort its license back in January 2002 despite persisting safety concerns at its vaccine production facility in Michigan. 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. Hauer would later join the board of BioPort, after it reformed as Emergent Biosolutions, in 2004.

Such examples of cronyism are more common than not when it comes to Emergent Biosolutions. Indeed, the company has frequently relied on individuals who spend their careers passing through the “revolving door” between the pharmaceutical industry and government, particularly those who also moonlight as bioterror alarmists. One of the main individuals critical to the company’s success over the years has been Robert Kadlec. Kadlec served as the top bioterror advisor to the Pentagon in the weeks leading up to the 2001 anthrax attacks. Months prior, he had participated in the June 2001 simulation Dark Winter, which “predicted” major aspects of the subsequent anthrax attacks. Kadlec subsequently crafted much of the legislation that would create the country’s subsequent bioterror/pandemic response policy, including BARDA and the Strategic National Stockpile.

Soon after leaving government, Robert Kadlec helped found a new company in 2012 called “East West Protection,” which develops and delivers “integrated all-hazards preparedness and response systems for communities and sovereign nations.” The company also “advises communities and countries on issues related to the threat of weapons of mass destruction and natural pandemics.”

Kadlec formed the company with W. Craig Vanderwagen, the first HHS Assistant Secretary for Preparedness and Response (a position Kadlec had helped write into law and would later hold himself). The other co-founder of East West Protection was Fuad El-Hibri, the founder of BioPort/Emergent Biosolutions, who had just stepped down as Emergent’s CEO earlier that year.

Kadlec then became a consultant. Kadlec’s consultancy firm, RPK Consulting, netted him $451,000 in 2014 alone, where he directly advised Emergent Biosolutions as well as other pharmaceutical companies like Bavarian Nordic. Kadlec was also a consultant to military and intelligence contractors, such as the DARPA-backed firm Invincea and NSA contractor Scitor, which was recently acquired by SAIC.

Kadlec would return to government as HHS ASPR under Trump, a position which he held at the time the Covid-19 crisis began. The year prior, in 2019, Kadlec had conducted a months-long simulation focused on a global pandemic originating in China called Crimson Contagion. Once the Covid-19 crisis began in earnest, he played a major role in securing Covid-19 vaccine contracts for Emergent Biosolutions, despite his conflicts of interest, some of which he had declined to disclose upon being appointed to serve as ASPR.

Emergent Biosolutions’ pattern of corrupt behavior, beginning with its anthrax vaccine, can be seen with its recent actions as it relates to its production of Covid-19 vaccines. Per the recent Congressional report, released just days before the recent spike in concern over monkeypox began, Emergent lab workers “intentionally sought to mislead government inspectors about issues” at its Baltimore-based plant and also repeatedly “rebuffed” efforts by AstraZeneca and Johnson & Johnson to inspect their facilities. “Despite major red flags at its vaccine manufacturing facility, Emergent’s executives swept these problems under the rug and continued to rake in taxpayer dollars,” House Oversight and Reform Committee Chairwoman Carolyn Maloney (D-NY) stated upon the report’s release. Yet such “major red flags” can be found throughout the company’s entire history, for those willing to take the time to look.

Just days after the Congressional report was released, Emergent Biosolutions announced that it would acquire the exclusive worldwide rights to the “first FDA-approved Smallpox Oral Antiviral for all ages” from the company Chimerix. The drug, called TEMBEXA, is only for the treatment of smallpox, which the company refers to as “a high priority public health threat.” The press release on the company’s acquisition of TEMBEXA states that multi-million US government contracts for the product are anticipated. The FDA formally approved the drug last June.

Emergent Biosolutions also has the rights to the smallpox vaccine known as ACAM2000, which can also be used to treat monkeypox. The vaccine, originally produced by Sanofi, was acquired by the company in 2017. As a result, the company has an essential monopoly over smallpox vaccines as ACAM2000 is “the only vaccine licensed by the FDA for active immunization against smallpox disease for people determined to be at high risk of smallpox infection.”

Given their track record, it’s worth asking why Emergent Biosolutions has been working in recent months to pivot much of its business into smallpox treatments. However, there is no speculation needed when observing that the current monkeypox fears and helping rescue the company, whose shares had fallen some 26% year to date before concern over the recent monkeypox outbreak began to grow.

Whatever comes of the monkeypox situation, Emergent Biosolutions’ decades-long track record is undeniably one of corruption and cronyism.

“BioArmor” for Ron Perelman’s Flailing Business Empire

SIGA Technologies, which likens its products to “Human BioArmor”, features a quote from Bill Gates at the top of its about page. The quote reads: “[…] the next epidemic could originate on the computer screen of a terrorist intent on using genetic engineering to create a synthetic version of the smallpox virus […]” The quote is from Bill Gates’ speech to the 2017 Munich Security Conference, where he used the threat specifically of smallpox to argue that “health security” and “international security” be merged. Notably, last March, the Munich Security Conference hosted a simulation of a global pandemic caused by a “genetically engineered monkeypox virus.”

SIGA is one example of a company that seeks to find its niche in the middle of “health security” and “international security.” It specifically provides “solutions for unmet needs in the health security market that comprises medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats, as well as emerging infectious diseases.” The majority of contracts for CBRN medical countermeasures in the US are funded by the Pentagon. While it promotes itself as a CBRN threat-focused company, SIGA is, for now, singularly focused on smallpox.

Indeed, SIGA Technologies is only currently profitable in the event of an actual outbreak of smallpox or a related disease, or when fear of a smallpox bioterror event is high. Specifically, concern over the latter has led to the company to win government contracts to produce TPOXX for the Strategic National Stockpile (SNS). This is because TPOXX is only used to treat active smallpox or monkeypox infection, not prevent it. This means that it is only useful if smallpox, monkeypox or a related disease is actively infecting people or if there is a high risk that one of these diseases will soon infect large groups of people. TPOXX was first approved in 2018 by the FDA and was approved by the European Medicine Agency (EMA) this past January. The FDA approved an intravenous version of TPOXX just this past Thursday. Overall, SIGA has received over $1 billion from the US government to develop TPOXX.

SIGA is currently partnered with HHS’ BARDA, the Department of Defense, the CDC and the NIH. Another partner is Lonza, a European pharmaceutical manufacturing firm that is partnered with both the World Economic Forum and Moderna. SIGA’s CEO, Phillip Gomez, is an alumni of PRTM Consulting, where he would have worked closely with Robert Kadlec, as the two men overlapped as directors of the firm and both worked advising government agencies on matters of public health and biodefense.

SIGA is also notable because it is possibly the only company in the business empire of corporate raider Ron Perelman that is not attached to growing mountains of debt. Perelman is one of the notorious corporate raiders from the 1980s who conducted corporate takeovers fueled by junk bonds, particularly those connected to Michael Milken’s Drexel Burnham Lambert. Perelman’s business tactics have long been informed by his volcanic temper and his ruthlessness, with former Salomon Brothers CEO John Gutfruend once remarking that “believing Mr. Perelman has no hostile intentions is like believing the tooth fairy exists.”

Perelman is also known for being a long-time patron of the Clinton family, even though, more recently he donated to Donald Trump’s political campaigns. Perelman apparently first became interested in courting influence with the Clintons after marrying Patricia Duff in 1994. Duff was deeply connected to the Democratic Party, having worked for Democratic pollster Pat Cadell, and she had also worked for the House panel that “investigated” the assassinations of John F. Kennedy and Martin Luther King Jr. Prior to marrying Perelman, she had been married to movie mogul Michael Medavoy and had “introduced Clinton to the Hollywood establishment,” according to the Washington Post.

As Perelman’s wife, Duff styled herself a leading Democratic fundraiser, with the 1995 fund-raising dinner being emblematic of that. Also, in 1995, Perelman attended a $1,000-a-plate dinner in New York for the Clintons, where Perelman sat across from the President, as well as a state dinner for Brazil’s president at the White House.

For Perelman, his generosity to the Clinton political machine resulted in an appointment by Clinton to the board of trustees of the Kennedy Center in 1995. Other, less public gestures from the Clintons were likely, as Perelman offered much more to the First Family than he appears to have received in return. Perhaps most notable of Perelman’s favors for Bill Clinton was his offering of jobs to scandal-ridden members of his administration, Webster Hubbell and Monica Lewinsky, in the wake of their respective controversies. However, after the job offers were publicly reported, both Hubbell and Lewinsky were let go, though the offers later caught the attention of independent counsel Ken Starr. Starr never subpoenaed or investigated Perelman or the offers he had made to Hubbell or Lewinsky.

The controversial hirings had been arranged between Perelman and Clinton advisor Vernon Jordan, who sat on the board of Revlon, a Perelman-controlled company, while his wife was on the board of another Perelman-owned firm. Jordan was known as Clinton’s “conduit to the high and mighty” and had taken Clinton to the 1991 Bilderberg conference. On the decision to hire Lewinsky following the scandal, a former business associate of Perelman’s told the Washington Post that “It’s like the Mafia, it’s all done in code,” adding that “I can assure you that Ronald made the decision to give Lewinsky the job. And I can assure you he wouldn’t want to know why Jordan was asking.”

In 1995, Perelman held a Clinton fundraiser at his mansion, with guests including singer Jimmy Buffett, Miami Vice actor Don Johnson, actor Michael Douglas’ then-wife Deandra and DNC co-chair Don Fowler. Other guests included A. Paul Prosperi, a corrupt Clinton crony, and the now infamous Jeffrey Epstein. Clinton himself attended the fundraiser. According to the Palm Beach Post, guests had donated at least $100,000 to the DNC to attend the dinner with the President. This was, of course, in the lead up to the 1996 election, and the DNC would later come under heavy scrutiny due to illegal fundraising. This fundraiser was not Epstein’s only interaction with Perelman – Perelman would later be listed as a frequent dinner guest of Epstein’s in the 2003 Vanity Fair profile penned by Vicky Ward and is listed in Epstein’s black book of contacts.

For most of the 2000s, Perelman has sat atop a massive, ever-growing fortune. Yet, since 2020, Perelman has “been unloading assets ‘A lot of them. Rapidly.’” It started with sales of valuable paintings at Sotheby’s and soon extended to Perelman’s investment company MacAndrews & Forbes, which disposed of its interest in two companies that same year, including $1 billion in shares in Scientific Games. According to MoneyWeek, Perelman’s net worth dropped from $19 billion in 2018 to $4.2 billion in late 2020, “prompting speculation that he’s running out of money.” Over the course of last year, Perelman has continued to “downsize”, looking to sell off his estate in the Hamptons for $115 million, another 57-acre estate worth $180 million and two townhouses in Manhattan’s Upper East Side for $60 million.

Other assets held by Perelman’s company MacAndrews & Forbes are also drowning in debt. One of the few assets of the company that isn’t currently haemorrhaging money or struggling with debt is its shares in SIGA Technologies. Perelman’s main company, MacAndrews & Forbes, has long been one of SIGA’s biggest investors and remains its largest shareholder, controlling 33% of all shares.

Since Perelman got involved with SIGA, accusations of corruption have plagued the company. For instance, in May 2011, SIGA was given a no-bid contract worth about $433 million to develop and produce 1.7 million doses of anti-viral drug for smallpox. At the time there was no evidence the smallpox drug in question was capable of treating the disease and there was alarm among some HHS staffers that SIGA’s return on investment from the contract was “outrageous.” The contract began to be investigated over concerns that the contract had been awarded to SIGA precisely because it was controlled by Perelman, who had donated heavily to Barack Obama. At the time, CNN noted the following about Perelman’s connections to the Obama White House:

“Ronald Perelman is controlling shareholder of Siga Technologies and a longtime Democratic Party activist and fundraiser. He’s also a large contributor to Republicans, but has been a particular friend of the Obama White House.

Also on Siga’s board of directors is Andy Stern, former president of the Service Employees International Union, who has had close relations with the Obama administration and who has supported President Barack Obama’s health care initiatives.”

As a result of these concerns and the potential conflict of interest, a congressional investigation began. Days after learning that this key government contract may be in jeopardy, SIGA executives sold off large amounts of company stock at an average price of $13.46 per share, netting its Chief Executive Officer and Chief Scientific Officer at the time millions of dollars. A month later, the company announced that its contract had been downsized and shares in the company fell to under $2 by that December.

Given past “pay-to-play” accusations around Perelman’s role in the firm during the Obama administration, when President Joe Biden served as Vice President, what are we to make of the recent media hype around monkeypox? Or concerns raised last year of a bioterrorism event involving smallpox?

Perhaps it’s more important to ask other questions – why has Perelman’s role in SIGA been largely obfuscated or totally ignored by recent reporting on the company? Similarly, why has Emergent Biosolutions’ horrific track record also been excluded from recent reports, including the major complaints from Congress made against the company less than two weeks ago? It seems the fear being generated around monkeypox is not only boosting shares for these two rotten companies, it’s helping the public forget their past sins.

Whitney Webb has been a professional writer, researcher and journalist since 2016. She has written for several websites and, from 2017 to 2020, was a staff writer and senior investigative reporter for Mint Press News. She currently writes for The Last American Vagabond.

May 22, 2022 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular | , , , , , | 1 Comment

FDA gives Emergent BioSolutions a consolation prize: it must throw out 60 million vaccine doses but can sell 10 million, which will be labeled as failing GMP standards

By Meryl Nass, MD | June 11, 2021

Now this is a really odd FDA decision. FDA is acknowledging that the 10 million doses it is authorizing is adulterated. But adulterated doses can’t be sold. But EUA products don’t generally get sold, except to the US government. I am scratching my head. I thought all these doses were already bought and paid for, by the taxpayer.

And there seem to be another 100 million doses about which FDA has not made up its mind.

This echoes FDA’s decision last week to license a very expensive but ineffective Alzheimer’s drug, after its advisory committee unanimously voted against it.

We always knew FDA was a political organization. But now, without Biden having appointed anyone to its helm, its decisions are wilder than ever.

From the NY Times today:

WASHINGTON — Federal regulators have told Johnson & Johnson that about 60 million doses of its coronavirus vaccine produced at a troubled Baltimore factory cannot be used because of possible contamination, according to people familiar with the situation.

The Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or sent to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices.

The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months because of regulatory concerns, the people said.

The Johnson & Johnson doses administered in the United States so far were manufactured at the firm’s plant in the Netherlands, not by Emergent. For weeks the F.D.A. has been trying to figure out what to do about at least 170 million doses of vaccine that were left in limbo after the discovery of a major production mishap involving two vaccines manufactured at the Baltimore factory.

June 12, 2021 Posted by | Aletho News | , , , , | Leave a comment

The J&J Covid-19 vaccine is being manufactured by the anthrax vaccine company. This is its history

By Dr Meryl Nass, MD | May 19, 2021

Emergent BioSolutions will be in the spotlight today during a House Select Subcommittee Meeting on the Corona Virus Crisis, today at 10:30 am. It can be watched here.

Hybrid Hearing on “Examining Emergent BioSolutions’ Failure to Protect Public Health and Public Funds”

Below, I provide the backstory aka checkered past of this company.

DOD created a plan to vaccinate its service-members against many biowarfare threat agents in the 1990s. At the time, of the bioterrorism vaccines that were being considered, only anthrax and smallpox vaccines had licenses. Anthrax vaccine was chosen to initiate the program in March of 1998.

The first 2 million doses of anthrax vaccine came from a stockpile that had been made for the US army by Michigan’s state vaccine lab (Michigan Biologics Products Institute).  What became known in November 1997, after the FDA performed an inspection, was that most of the army’s 11 million dose stockpile of anthrax vaccine, stored at the Michigan lab, was multiply expired, had been redated, and was contaminated, with visible bacterial and fungal growth in some of the lots. FDA immediately shut down the anthrax vaccine factory, and quarantined 9 million of the 11 million existing doses. Unfortunately, FDA allowed the Defense Department to use 2 million doses, which it did over the next two years.

The Conclusions from FDA’s 1998 and 1999 inspection reports of the facility can be read here.

The Michigan state lab was a massive affair with many buildings on a campus in downtown Lansing. It produced a large variety of vaccines and blood products for the state of Michigan. However, over the years the state had not made the required repairs and updates. After the 1997 FDA inspection, Michigan had to repair the place or close it.  Michigan decided to sell, and looked for a buyer.

The former head of the Joint Chiefs of Staff, Admiral William Crowe, heard about the sale. He had come to know the el Hibri family when he was Ambassador to the UK. The el Hibri’s had purchased anthrax vaccine from the UK government laboratory at Porton Down just before the Gulf War, and resold it to the Saudi government at a 100x markup.

Crowe and the el Hibri family joined with several of the lab’s officials, and the newly formed group purchased the lab. The purchase price was about 19 million dollars. Admiral Crowe was given a 13% share in exchange for his role as Chairman of the Board, risking none of his own funds. Much of the cost was later paid by the transfer of vaccines to the state of Michigan.

The new company, formed in the first half of 1998, was named Bioport. It chose to focus on its sales of anthrax vaccine to the Army. However, the new company was deeply concerned about potential liability for the lab’s products. The purchase was delayed until the Secretary of the Army signed an indemnification for injuries that might result from use of anthrax vaccine in soldiers, and it also indemnified the company against claims if the vaccine failed to provide the expected protection against anthrax. The state of Michigan had also been indemnified by the Army to produce the vaccine. But from its 1970 licensure until 1998, almost all the anthrax vaccine had only been used in animal experiments.

After FDA had shuttered the anthrax vaccine plant for manufacturing defects, the Army paid to bulldoze and then rebuild the factory in 1999. But even after it was rebuilt, FDA withheld its approval, and the plant lay idle.

Meantime, the 2 million doses that FDA had failed to quarantine were injected into 500,000 military service-members between 1998 and 2001. Many thousands became ill.  An official report on the program, quoting unnamed government officials, claimed that 1-2% of recipients had developed permanent disabilities. The military  vaccinations were mandatory, and refusers were punished with a court martial or loss of a month’s pay and performance of extra duties. Nonetheless, seeing the injuries sustained by their colleagues, many refused.

In 2001, the anthrax vaccine label, a legal document that describes what is known about the product, listed the CDC’s definition of Gulf War syndrome as a possible adverse effect of the vaccine. (It has been removed from the current label.)

Five Congressional hearings were held throughout 1999 on different aspects of the anthrax vaccine program by the House Committee on Government Reform and National Security (now known as the House Committee on Oversight and Reform). Additional hearings held by other Congressional committees also touched on the vaccine program. The Government Reform and National Security Committee wrote up its findings in a report titled Unproven Force Protection. Its June 30, 1999 hearing dealt specifically with Bioport and its sole source contracts.

Despite this, Bioport has been very successful. Although the Pentagon was considering an end to the anthrax vaccine program in the summer of 2001, the sudden appearance of the anthrax letters after the September 11, 2001 attacks breathed new life into the vaccine program and turned Bioport’s fortunes around. DHHS Secretary Tommy Thompson announced in November 2001 that the anthrax vaccine plant would finally receive an FDA approval and begin production. At the end of January 2002 that is what happened.

But that was not the end of Bioport’s problems.  Soldiers challenged the legality of the vaccine’s license in federal court. It was learned that while there had been efficacy testing of an earlier version of the vaccine, the current vaccine formulation had never undergone either efficacy or safety testing in a clinical trial. Aware of this major omission, FDA had withheld the issuing of a “final rule and order” for the anthrax vaccine for over thirty years.

The soldiers prevailed on the legal issues, and First District Court Judge Emmett Sullivan rescinded the vaccine license in 2004, based on the company’s failure to prove efficacy or meet basic FDA standards for licensure.

Unwilling to bow to judicial authority, the Defense Department rolled out a backup plan. A new regulatory authority had just been created, the Emergency Use Authorization (EUA). An EUA was slapped on the unlicensed anthrax vaccine, and DOD quickly restarted its mandatory vaccinations. (There was no emergency: the issuing of an EUA required only the potential for an emergency.)

The attorneys for the soldiers took the case back to court, and Judge Sullivan ruled that even if an experimental medical product received an EUA, it was still investigational and could not be mandated. The law required that EUA products be offered with informed consent. To receive an EUA (unlicensed) product, the recipient must be apprised of the risks and benefits of the product, be informed of alternatives to the product, and no coercion in any form could be applied. Ergo, no mandate.

FDA waited about 18 months, and then issued a full license for Bioport’s anthrax vaccine, although there were still no efficacy data. FDA instead claimed that a 1950’s era trial of a very different anthrax vaccine was sufficient for licensure, even though that trial failed to show benefit against inhalation anthrax.

When the soldiers and their attorneys challenged the licensing decision in court, the next judge ruled in favor of FDA on the basis of “deference”—meaning that FDA could ignore its own regulations when making a determination on safety and efficacy, with or without acceptable data. In 2006 mandatory vaccination restarted.

Bioport then shed its old skin in an attempt to leave its baggage behind. It renamed itself Emergent BioSolutions. Its vaccine had been renamed BioThrax.

Emergent BioSolutions (EBS) then branched out, buying other companies, primarily those making other sole source biodefense products. The military continued to mandate anthrax and (in 2003) smallpox vaccines for service-members. Eventually EBS purchased the smallpox company as well, and the cholera and typhoid vaccines used in the US.

A 2010 report on Emergent BioSolutions, written by Scott Lilly for the Center for American Progress, was titled, “Getting Rich off Uncle Sucker.” It revealed 300% profit margins, unique for a government contractor.

The company’s business plan was to rely on insiders to sell sole source biodefense products to the US government, most of which were stockpiled and never used–inking contracts with multiple federal agencies, including CDC, DOD, NIAID, the State Department, ASPR and BARDA.

In 2012 EBS got one of three DHHS contracts to house a so-called Center for Innovation in Advanced Development and Manufacturing (CIADM) that could be used to produce pandemic or biodefense products in the event of emergencies. With this grant EBS purchased and expanded what became its Bayview factory in Baltimore. The CIADM contract essentially guaranteed Emergent a big role in any future pandemic response.

Emergent acquired the maker of Narcan nasal spray, the opioid overdose antidote. Soon FDA began recommending to prescribers that they write a Narcan script whenever they wrote a narcotic script, just in case. States started buying large quantities for free distribution. Sales rose 600% after EBS bought the company.

Under the Trump administration, retired Air Force Colonel, physician and biodefense consultant Robert Kadlec was appointed to the position of Assistant Secretary of DHHS for Preparedness and Emergency Response (aka ASPR). Kadlec had also been a consultant and business partner of EBS’ founder and chairman Fuad el-Hibri. Kadlec had omitted this information from the required disclosures for Senate confirmation. Once confirmed as Assistant Secretary, Kadlec was able to transfer responsibility for the National Strategic Stockpile (containing the US stockpiles of pandemic remedies, masks and equipment) from the CDC to his own agency. Kadlec then gave multiple sweetheart deals to EBS, until the value of EBS’ contracts with ASPR exceeded those of every other contractor.

ASPR Kadlec was blamed for cancelling a federal contract to make N95 masks while buying more and more anthrax and smallpox vaccines, pre-Covid.

Covid-19 presented a huge opportunity for Emergent BioSolutions. EBS received $628 million from DHHS to retool its CIADM factory. It inked additional contracts with the Astra-Zeneca, Johnson and Johnson, Novavax, Providence Therapeutics and VaxArt companies to provide bulk manufacturing of their vaccines in its Baltimore facilities. Altogether its pandemic contracts were worth about $1.5 Billion. It was slated to manufacture 9 separate medical products to address Covid-19, all designed by other companies.

But there were serious potential problems.

While it had a storied Board of former federal officials, Emergent BioSolutions had never brought a single product to market. Its expertise was in contracting and acquisitions, not production. It had a history of production failures, and had demanded that the federal government bail the company out, or else the sole source products the company provided would become unavailable. Some of this was detailed in the Congressional report Unproven Force Protection. Entering the pandemic, EBS was still making the same mistakes it had been guilty of twenty years earlier:

EBS did not have an active workforce in Baltimore. On September 30, EBS held an online job fair which it titled “Warp Speed Careers Event.” The event sought to recruit 300 employees. Yet EBS had begun inking vaccine contracts 5 months earlier, and could have hired and trained a workforce that was ready to go when FDA gave it the go-ahead.  Instead, doing things on the cheap, EBS hired late, failed to provide adequate training to its employees, and experienced a spectacular series of production failures. Many millions of doses of its Johnson and Johnson and its Astra-Zeneca Covid vaccines had to be dumped. J and J missed its 20 million dose quota for the end of March, and FDA, despite repeated inspections, would not give the plant an authorization so its products could be used.

Despite this, somehow millions of doses produced in the unauthorized plant were shipped to Canada, the European Union, South Africa and Mexico. The EU, at least, used the product. How did that occur? We don’t know. Did any get distributed in the US? We can’t be sure none did.

On April 4, 2021, EBS announced it would receive an additional $23 million from DHHS for new equipment to use in the manufacture of Johnson and Johnson’s Covid-19 vaccine.

As of last week, EBS was facing another lawsuit from its shareholders, and its stock price had fallen to $60 from the peak on February 12 of $125 per share. However, Emergent CEO Robert Kramer exercised his stock options in January and February, near the stock’s peak, earning himself over $7 million dollars in profit.

In summary, EBS, despite considerable manufacturing shortcomings, has been extremely successful at obtaining government contracts and earning huge profits. But its products have repeatedly been unreliable. The company has managed to turn failures into success, especially when its products, like civilian stockpiles of anthrax and smallpox vaccine, and nerve gas auto-injectors, are stockpiled but not used.

The public has only gradually been learning that the vaccines it thought were being produced by huge Pharma companies Astra-Zeneca and Johnson and Johnson were in fact being manufactured by the anthrax vaccine company, Emergent BioSolutions. How did it come to pass that the federal government, and these established pharmaceutical companies, bet the farm on EBS’ production of Covid-19 vaccines?

May 19, 2021 Posted by | Civil Liberties, Corruption, War Crimes | , , , , , , , | Leave a comment