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Emergent Biosolutions and anthrax: how a pharmaceutical company fleeces the American public year after year

2021-05-02

Emergent Biosolutions is a privately owned pharmaceutical company whose main business is supplying anthrax vaccine to the American government. The government maintains doses in the Strategic National Stockpile (SNS.) The SNS, previously called the National Pharmaceutical Stockpile, is the main repository of emergency medical equipment kept by the federal government of the United States (US.)

The Strategic National Stockpile

According to Wikipedia, “[The SNS] contents include broad-spectrum oral and intravenous antibiotics, emergency medicines, IV fluids and kits, airway equipment, bandages, vaccines, antitoxins, and ventilators. The material deploys by unmarked trucks and airplanes within 12 hours of the receipt of a request by the CDC.” Some states also have their own stockpiles as well. These supplies are meant to help the people in the event of an outbreak of serious disease.

The predecessor to this stockpile was an un-named supply of medical supplies in 32 regional storage facilities accumulated during the Cold War. These supplies began to degrade, and the program was officially closed in 1974.

In 1998, then-president Bill Clinton read a fictional account about a terror attack with a virus in New York City. He was so impressed by this book that he convened a group of bio-terror experts and Cabinet officials to discuss the problem. The result was a law that he signed in October 1998 establishing the National Pharmaceutical Stockpile with an initial appropriation of $51 million. Prior to this law, only the military had been stockpiling essential drugs and equipment for its own use.

Over the succeeding years, the stockpile added personal protective equipment (PPE) and vaccines. The federal government used the stockpiles after such incidents as the terror attacks on September 11, 2001, major hurricanes like Katrina and Rita in 2005, Superstorm Sandy, and the H1N1 influenza outbreak in 2009.

Experts at the SNS developed Federal Medical Stations (FMS) and deployed them to provide medical care in cases where hospitals were destroyed or overwhelmed. The SNS included 50 and 250 bed versions of the FMS.

In the 2009 influenza pandemic the SNS distributed large quantities of Tamiflu and Relenza (drugs effective in the treatment of influenza) and most of the stockpile of N95 face masks. These were not replenished due to budgetary constraints ($600 million annual budget) when it was felt that other items were more important. As a result, at the outset of the coronavirus pandemic there was a dire shortage of N95 face masks for distribution.

During the years 2017-2019, the federal administration failed to act on warnings that the stockpile of N95 face masks needed augmentation and replacement (many of the masks were expired and had flexible straps that had become brittle.) According to Wikipedia, ” As of March 2020, the national strategic stockpile had 40 million masks while 100 times more were expected to be necessary to handle the pandemic crisis.”

The SNS is hobbled by the expense of purchasing anthrax vaccine, which uses up half of its yearly budget.

Anthrax and bioterrorism

Anthrax is a very rare but deadly bacterial infection which humans acquire from animal sources, mostly cows and goats. The incidence of human anthrax has dramatically declined over the last 150 years, in part because Pasteur pioneered a vaccine for animals in 1881– one of the earliest vaccines to be achieved, after smallpox.

Anthrax is unusual among bacterial diseases in that an inactive form of the bacterium, a spore, is present in the soil. The bacterium reverts to spore form when its animal host dies, and in this form it can persist for decades or even centuries.

The spore form of anthrax is nearly ideal for use in bioterrorism since it can be produced in large quantities and powdered to produce an inhaled weapon. The spores penetrate deep into the lungs, where they germinate within immune cells over a period of a few days (up to 60 days in rare cases.) Once symptoms develop, the victim dies within a couple of days, so treatment is often too late unless it is started before the symptoms appear.

Anthrax has been studied and developed as a terror weapon since The Great War (World War One.) The most ambitious known program was undertaken in Great Britain during World War Two (WW II.) The Japanese studied anthrax and other bioweapons in Manchuria from 1932 to the end of WW II, and sprayed anthrax over Chinese cities. Despite an international treaty banning bioweapons signed in 1972, the Soviet Union maintained a secret anthrax program that was not abandoned until after the Union was disbanded; it may still be extant.

The most serious incident of the twentieth century took place in Sverdlovsk (now known as Ekaterinburg) in the Soviet Union in 1979. A cloud of anthrax spores was accidentally released from a weapons facility in Sverdlovsk that infected about 96 people (the exact number is unknown) and killed about 68. The full story of this outbreak did not come out until 1994. A good summary account of the history of anthrax as a weapon and the Soviet incident can be found here.

In 1995, inspectors discovered that the Iraqi government of Saddam Hussein was developing anthrax as a weapon. The Army decided to protect soldiers by using the anthrax vaccine that had been approved in 1970. Even before this, during the Gulf War, the military vaccinated front-line soldiers. The SNS began to add anthrax vaccine to its stockpile after an incident in the US in 2001.

Anthrax as a terror weapon in the United States

In October 2001, doctors discovered cases of inhalational anthrax in scattered locations on the East Coast after the Postal Service delivered letters containing anthrax to news agencies and two Democratic Senators. A total of eleven people came down with inhalational anthrax, and five of them died. Eleven more cases of cutaneous anthrax occurred, with no fatalities. Forty-three other people tested positive for anthrax infection without symptoms, although thousands of others were thought to have been exposed.

Numerous low-level exposures to anthrax spores may have occurred; the minimum lethal dose of spores is thought to be between 10,000 and 40,000. Modern detection methods may find tiny quantities of spores.

The Federal Bureau of Investigation (FBI) carried out extensive investigations that ended in 2008 with the suicide of the prime suspect (who worked directly with anthrax in a government laboratory.) The suspect may have been motivated by a desire to call attention to the need for better protection against the use of anthrax as a terror weapon. He was also described as being “sociopathic and homicidal.”

Anthrax vaccine and the SNS– this is where Emergent comes in

Emergent Biosolutions began life as BioPort in 1998 and changed its name in 2004. At its inception, BioPort bought an anthrax vaccine manufacturing facility (and the rights to produce the vaccine for the US military) from the State of Michigan, located in Lansing, MI. After changing its name, Emergent acquired several other pharmaceutical companies.

For example, in February 2014, it bought Cangene, a company which made three products for the SNS:  Heptavalent botulism antitoxinVaccinia immune globulin, and Anthrax immune globulin. Cangene also made WinRho, an immune globulin used for hemolytic disease of the newborn and immune thrombocytopenic purpura. Other immune globulin products made by Cangene include those for exposure to hepatitis B and varicella. All of these are specialty products with small markets.

The Bayview, Baltimore plant (discussed below) was the location of an attempt to create a vaccine against the poison ricin in 2017-20. Ricin is a potential bioterrorism toxin which is easy to obtain from castor oil and is extremely potent. The vaccine would have been a prime candidate for purchase by the SNS.

Another product made by Emergent is a skin lotion that neutralizes the nerve agents VX, VR, and soman, which are popularly known as “nerve gas.” This product is supplied to the military and to the SNS; it is also available to the public..

Emergent’s Bayview, Baltimore production plant– not ready for prime time.

Some eight years ago, Emergent entered into a contract with the US government to have a manufacturing facility ready to produce vaccines in case of a pandemic. As a part of the contract, the company was required to show its capabilities by producing 50 million doses of influenza vaccine within four months. The deadline for this “stress test” was June of 2020. However, it never performed the test. Delays in selecting an appropriate vaccine were blamed for its failure.

This facility is being used to produce the Johnson and Johnson (J+J) coronavirus vaccine and the AstraZeneca vaccine. It has not yet been certified by the government, however, and recent developments suggest that it may not be ready for some time.

The company announced at the end of March that it would have to destroy up to 15 million doses of the J+J vaccine because they had been contaminated by the AstraZeneca vaccine. Audits and investigations by the federal government, the vaccine companies, and Emergent itself, “found that Emergent had not followed some basic industry standards at the Baltimore plant, and identified repeated shortcomings in efforts to disinfect and prevent contamination.” (New York Times, April 6, 2021)

As a result of this disaster, J+J has taken over administration of the plant at the direction of the federal government and is limiting it to production of the J+J vaccine only. The Associated Press reported on March 31 on a series of inspections at the Bayview and Camden facilities in Baltimore as well as one in Canton, Massachusetts. These inspections revealed a number of serious deficiencies in the production processes at those plants.

How did Emergent get this way? By lobbying the federal government.

Emergent spent over $3.6 million on lobbying in 2020. It has benefitted during the last Republican federal administration by having a highly placed official, Dr. Robert Kadlec, gain control over the SNS. Dr. Kadlec was formerly a consultant for Emergent. The company has carved out a lucrative niche by being (or acquiring) the sole supplier of several critical vaccines and other drugs for the SNS. It was perfectly placed to get a large contract to supply coronavirus vaccine last year.

Based on the inspections, it appears that Emergent’s corporate culture doesn’t seem to be very interested in quality control.

Emergent has misrepresented its Bayview, Baltimore plant as being ready to take up manufacture of large quantities of vaccine for the federal government and pharmaceutical companies, despite having failed to perform the necessary “stress tests” to prove that it can do so. It has profited greatly from its misrepresentation and its lobbying connections to government.

The situation at Emergent is scandalous, but it is only one of many pharmaceutical industry companies that have been doing much the same things, with the connivance of government. Something needs to be done to clean up this industry.

photo by Liz Masoner via pixabay.com

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