“Company Set to Manufacture COVID-19 Vaccine for US Intentionally Sold Faulty Biodefense Products”

August 20, 2020 | Author:  | |

“Evidence of the corruption of the company Emergent BioSolutions has emerged yet again as the firm, set to play a key role in the manufacture of four leading COVID-19 vaccine candidates, has been caught selling the US government a biodefense product it knew was non-functional.

Internal documents and e-mails from the “life sciences” company Emergent BioSolutions reveal that the company was aware that its biodefense product for the treatment of nerve gas exposure, sold under the brand name Trobigard, was both non-functional and untested for safety or efficacy while it was actively marketing the product to the U.S. government.

The firm was well aware of the fact that Trobigard’s functionality and safety in humans had never been tested several months before it was awarded a no-bid $25 million contract in October 2017 and a subsequent $100 million contract in 2019 to supply troves of the product to the State Department. Indeed, the results of the company’s first study on Trobigard’s efficacy in treating exposure to nerve gas were not even available until six weeks after Emergent had won the contract with the State Department and, even then, those results could “not be directly extrapolated to the human situation,” per the study’s authors.

According to internal company records and emails from Emergent employees and government officials obtained by The Washington Post, Emergent’s director of regulatory affairs, Brenda Wolling, stated in July 2017 that “functionality testing has not been successful in this device [Trobigard]” and that even describing Trobigard as “a treatment of nerve agent poisoning” was inaccurate because that claim “implies that we have efficacy data showing it works.”

Emergent BioSolutions declined to answer if the inaccurate marketing claims that Trobigard had been tested for safety and efficacy had been made to State Department officials prior to the awarding of the first contract for Trobigard in October 2017. The company did, however, state that Wolling’s claims had been “taken seriously” but that they did “not necessarily represent the company’s position.”

Notably, Wolling had sent internal warnings about Trobigard to colleagues a year prior, in 2016, telling Emergent salespeople to “exclude efficacy claims” about the biodefense product when marketing it to potential buyers. She specifically stated that “we have not substantiated that this co-formulated product is efficacious or safe, and have never tested against nerve agents as an antidote.” Also in 2016, a former Emergent executive, Dan Mallon, was also found to have admitted to Emergent employees that “Emergent sales representatives had made unsupported claims about Trobigard to clients.”

Even Emergent’s spokeswoman Nina DeLorenzo has since openly acknowledged that “Emergent has not tested the safety or efficacy of atropine and obidoxime co-formulated,” meaning that the combination of the two drugs that compose Trobigard has never been found to be safe or even work.

“Emergent made clear to government agencies interested in procuring Trobigard that they were doing so based on their own determination of need, without this type of safety or efficacy data from Emergent,” DeLorenzo told The Washington Post, essentially declaring that Emergent’s policy with respect to Trobigard is that of “buyer beware.”

Yet, some of Trobigard’s issues were so glaring and obvious that they resulted in public recalls, with the company recalling 61,000 units that had been sold to the United Arab Emirate in January 2019. While Emergent’s contract with the State Department obligated them to report “any issues with the safety and efficacy of delivered or ordered products and/or manufacturing or quality of the production lines” in a timely manner, the company argued that the recall in the UAE was unrelated to the State Department’s orders of Trobigard because they were different production batches. A similar recall was later made with units of Trobigard that had been sold to Italy’s government and Emergent chose to notify the State Department on that occasion. Trobigard had also been plagued with production issues, such as that which resulted in the discoloration of Trobigard injectors following sterilization, referred to as the “red spots” issue in company records.

The end result of Trobigard’s troubles was ultimately Emergent’s quiet decision to re-list it as a product in development as opposed to a marketable product on its website and to require that all future sales of Trobigard be approved by Emergent’s medical, legal and regulatory departments. However, Emergent has maintained that the Trobigard injectors sold to the State Department are safe, despite having admitted that no safety or efficacy tests of the product in humans have ever been conducted. The company has continued to receive payments from their multi-million dollar contracts with the State Department, the last of which was made last September.

Trobigard’s numerous issues appear to be precisely why Emergent sought to market the troubled product to the State Department in the first place, as marketing the product for use by U.S. diplomats overseas allowed Emergent to avoid needing the approval of the U.S. Food and Drug Administration (FDA), which is necessary for the product’s sale within the United States. In order to facilitate Trobigard’s sale without FDA approval, Emergent sold Trobigard to the State Department through a subsidiary based in the U.K. and had the injectors assembled in Europe where the finished product was then sent to U.S. embassies around the world. Trobigard is not currently approved for use by the health authorities of any nation.

An Abysmal Track Record Gets Worse

Despite Emergent’s rather nefarious efforts to duplicitously market faulty and untested biodefense products, the Department of Defense recently awarded them a contract worth up to $75 million to “develop other injectors for potential use by troops to counter certain kinds of chemical attacks.” Emergent BioSolutions, particularly before the company restructured and changed its name from BioPort in 2004, has long been notorious for its close “revolving door” ties to the Pentagon as well as the Department of Health and Human Services (HHS) in addition to its intimate involvement in the Anthrax vaccine scandal where the Pentagon was found guilty in 2004 of illegally using Emergent’s anthrax vaccine in an “experimental” and “off-label” way on U.S. troops.”

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