Don't trust Emergent BioSolutions

A few days ago the FDA approved the reopening of the Baltimore facility owned and operated by Emergent BioSolutions that originally was slated to produce large amounts of Johnson & Johnson's CoViD-19 vaccine.

As a reminder of why this matters:

The F.D.A. had halted production at the factory in late March after it was discovered that workers had accidentally contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used in AstraZeneca’s, then made at the same site.

I never got around to posting about Emergent BioSolutions before this but I've followed news of its travails with anger and disgust.

This NYT piece discusses how Emergent came to exploit the federal government's worry over anthrax even as the nation faced shortages of personal protective equipment in the early days of CoViD-19. The company sucked up a lot of money that might have been more productively spent.

Because Emergent was the sole manufacturer of a product deemed critical to national security, the company has played what one former executive described to The Times as “the we’re-going-to-go-bankrupt card.”

Profiteering isn't necessarily a crime but it isn't exactly morally upright, either.

Another NYT piece, "U.S. Bet Big on Covid Vaccine Manufacturer Even as Problems Mounted", revealed yet more damning facts about Emergent.

More than eight years ago, the federal government invested in an insurance policy against vaccine shortages during a pandemic. It paid Emergent BioSolutions, a Maryland biotech firm known for producing anthrax vaccines, to have a factory in Baltimore always at the ready.

When the coronavirus pandemic arrived, the factory became the main U.S. location for manufacturing Covid-19 vaccines developed by Johnson & Johnson and AstraZeneca, churning out about 150 million doses as of last week.

But so far not a single dose has been usable because regulators have not yet certified the factory to allow the vaccines to be distributed to the public. Last week, Emergent said it would destroy up to 15 million doses’ worth of the Johnson & Johnson vaccine after contamination with the AstraZeneca vaccine was discovered.

Why and how did the company blunder into this and other disastrous fiascos documented in this article?

... four former company officials, speaking on the condition of anonymity because they had signed nondisclosure agreements or feared retaliation, described an environment where top Emergent leadership tolerated and even encouraged the flouting of federal standards for manufacturing and marketing products.

One of the former officials said that as the company scrambled to meet the heavy demands of vaccine production, a senior manufacturing supervisor often responded to reports of quality errors by asking: “Do you want me to make drugs or fix issues? I don’t have time to do both.”

This second Times piece is required reading if you want to understand why you shouldn't feel relieved the Baltimore plant is reopening. The story behind its original closure reveals a management team that put profits above quality and responsibility, and a governmental bureaucracy that let the company get away with its recklessness (and make a ton of money in the process) despite being charged with protecting the public.

From the piece about the Baltimore plant's reopening (the first article I referenced):

“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” Robert Kramer, the chief executive of Emergent, said in a statement on Thursday.

Bullshit. Pardon my French, Kramer, but bullshit.

From that same piece:

Mr. Kramer announced that Sean Kirk, a longtime Emergent executive overseeing manufacturing who went on personal leave earlier this year after regulators found a host of problems at the Baltimore site, would be leaving the company.

Was Kirk solely responsible for the plant's terrible history of mismanagement? The article is silent about that, presumably because Kramer was, too. Emergent hasn't issued a report explaining how its Baltimore plant came to be such a disaster area, and I doubt it ever will of its own accord. In the absence of radical transparency from this outfit, how can we possibly believe, much less trust, that Kirk was the only bad apple?

I sure as hell don't think all the wasted time, money, and other resources were the result of just one executive's misdeeds and inaction. Emergent has a corrupt corporate culture and firing one executive is a laughably inadequate response to this episode.

J & J is assuming oversight of the Baltimore plant but that doesn't mean Emergent BioSolutions shouldn't face a reckoning. The federal government can't let one more penny slip into the company's coffers until there's a public accounting of who did what, and an objective assessment of how the hundreds of millions of dollars Emergent has received was spent. Anybody responsible for squandering that money, including by pocketing it while covering up fraud, has to be held accountable.