DARPA, Operation Warp Speed, and the Covid-19 Ka-ching Ahead

If/When Eli Lilly and AstraZeneca put out a viable Covid-19 solution in October, it won’t come as a surprise to DARPA.

The Department of Defense agency that ‘gifted’ the original Internet (ARPANET) to the world back in the 70s, set up the Pandemic Prevention Program (P3) shortly after Donald J. Trump’s presidential inauguration in January 2017. The highly ambitious principle function of P3 is to scramble scientists, pharmacies, and government agencies to combat pandemic outbreaks before they can savage a population. They want to be able to take any virus and come up with “a functionally integrated platform to deliver pandemic prevention treatments in <60 days.”

The process works like this: Grow a virus, find an antibody, evolve antibody. manufacture and deliver a solution. Here is their own explanation in detail and with illustrations. The P3 has been up and running for more than two years already. Working with partners, such as Lilly, AbCellera, AstraZeneca, GlaxoSmithKline, Genentech, and Amgen, they’ve conducted ‘war games’ against viruses, which are simulations of pandemics with their amped-up responses. Ostensibly, the system would be the solution.

As it turned out, an intergovernmental working group set up by the Department of Health and Human Services was there and ready. Officers of the DHHS’s Assistant Secretary of Preparedness and Response (ASPR) team took the first blood sample obtained from a Washington state patient who recovered from COVID-19 and, on February 25, handed it over to a DARPA partner, the privately held biotech company Abcellera in Vancouver, to immediately “evolve identified antibodies to high potency” in order to “deliver gene-encoded therapeutics.” Abcellera partnered with the pharmaceutical giant Eli Lilly to deliver the immune-reactive solution to the public. And on June 1, right as they said they could do, Abcellera and Lilly announced a viable stop-gap solution for Covid-19, pending a vaccine. Ta-da!

LY-CoV555

Describing how it works, Abcellera tells us that “LY-CoV555 is a highly potent, neutralizing IgG1 monoclonal antibody that targets the spike protein of SARS-CoV-2, the novel coronavirus that causes COVID-19. Its mechanism of action is designed to block viral attachment and entry into human cells, and to neutralize the virus, potentially preventing and treating COVID-19.” In short, LY-CoV555 creates an immune response that wards off Covid-19 as it tries to latch on. However, according to the government, the trial will not end, and outcomes known, until November 5 — just after the election. Meaning antibody treatments could begin in early November.

I have been corresponding with DARPA and Abcellera over the last few months regarding P3. Here is a condensed and lightly edited version of my more recent Q and A with DARPA:

Q: I’m amazed by a process that can identify candidate antibodies that quickly. Can you explain in layman’s terms how that works?

A: The P3 performers used proprietary microfluidic technologies to rapidly screen and select candidate antibodies.

Q: How could P3 be so sure that they’d meet the target of Aug 1, for testing?

A: Where science is concerned, you can never be certain that you will hit a milestone until proven, but based on the data received by that point we were fairly confident that we would meet the deadline.

Q: Can you confirm that the Solution will be distributed first to health workers (I realize the testing is being primarily in high risk environments).

A: Yes, it is our goal to have antibodies available for front line workers first, including healthcare workers, service members, and those with the most medical need.

Q: Is it repeatable? Once it wears off in weeks or months, can said subject repeat the dose and get relief again? (This would be an excellent universal Solution to get everybody back to work again – and to vote, while we are all waiting for a vaccine to be developed.)

A: One advantage of the gene-based platform capability is that it can be re-administered (no vector-based immune response). As a reminder, these are for near immediate, non-permanent protection and are not meant to be a replacement for vaccines.

Q: Following on from my assumption above, can this Solution be a stop-gap measure to get us to the vaccine? If so, how would that work?

A: Correct. The gene-encoded medical countermeasure provides protection in less than three days, but lasts only for months not days, and is not meant to be a replacement for vaccines. It’s a prophylactic for temporary protection before a vaccine is available or an immune response [is elicited].

Q: Assuming the tests go well, how long will it take for FDA approval? Will that process be accelerated? And what is the target date for actual public access to the antibody regimen solution?

A: We have no way of knowing how long it will take for FDA review. That process and timeline are up to the FDA, and DARPA — nor any other government agency — does not have the ability to request accelerated review.

Probab;y the most important Answer above is DARPA’s indication that the antibody treatment, though it stays in the bloodstream for only months, is re-administrable. It is an apparently solid “prophylactic” means of getting the masses to a vaccine. (Good way of making some money, too.)

Though DARPA claims that no accelerated review of data can be had — it would require breaking long-established clinical testing protocols — in a separate ‘miracle’ program run by DHHS, Operation Warp Speed, AstraZeneca is claiming it will have a vaccine available by October. The announcement, released back in May to little fanfare in the MSM, starts:

Responding to President Trump’s call to develop 300 million doses of SARS-CoV-2 vaccine by January under Operation Warp Speed, the U.S. Department of Health and Human Services (HHS) and AstraZeneca are collaborating to make available at least 300 million doses of a coronavirus vaccine called AZD1222, with the first doses delivered as early as October 2020.

Just in time for the election, one hopes. You know, a feel-good October Surprise for a change.

But not so fast. Operation Warp Speed isn’t even mentioned at AstraZeneca’s website. And even though the NYT reported on OWS a week before DHHS posted the above announcement, the paper of record was quick to point out that even getting the vaccine to market by January 2021 was absurd, given that “the fastest a new vaccine has been developed and distributed is four years and most have taken considerably longer.” The Times does not mention the more ambitious October date.

The head of OWS is Dr. Moncef Slaoui, a PhD in molecular biology and immunology. The Trump appointee was brought in because he is seen as a can-do kind of guy. His past work has included a $100m neuroscience research project in Shanghai. And he has called for more cooperation and pooling of resources among Big Pharma companies in situations, such as cancer and Covid-19, where the profit motive should be put aside for the public interest. Sounds good, but let’s not forget his personal ties to Big Pharma through GlaxoSmithKline and Moderna. These are potential conflicts of interest.

In 2013 article for HuffPost, “It’s Time to Further Incentivize Medical Innovation,” Slaoui called for three main changes to standard procedures:

1) Incentivize pre-competitive research

2) Incentivize antibiotics [and viral] discovery and development

3) Incentivize innovation by extending market exclusivity

He writes, “We need to encourage and develop more public-private partnerships to re-stimulate interest in antibiotics research and create realistic ways of paying for it.” In short, Big Pharma companies won’t “waste” money on R and D for solutions, if they will lose exclusivity to what they’ve developed. This is thought to be one of the reasons why attempts to find a “universal” vaccine has so far failed.

Public-Private partnerships always start out as Good Ship Lollipop enterprises. Feel Good miracle-of-medicine vibes are sugarplummed out to delight our belief in Man and our forward progress through history routine. However, Americans are capitalists, too. When we aren’t feeling good about our wonderfulness in the world, we like to make a buck. Ike, in his now infamous farewell speech, has duly warned us about the rise of the Military-Industrial Complex. And the public-private partnerships that could do good for humanity, often have secondary agendas, and when things go wrong with money issues, as they inevitably do, the eggheaded partners like to cook the books to cover up how they’ve conned us.

One of the first things likely to happen, and there already signs of it coming into play, are questions about who receives the medicine and how much it will cost — not unrelated questions. AstraZeneca and Eli Lilly, and others, stand to make zillions of dollars for medications they come up with — a lot of it as the result of research largely paid for by taxpayers, through, in this case, DARPA and Operation Warp Speed. There is a question of how much a dose would cost.

A Business Insider piece earlier this year considers that question. Author Zera Sherrell points out an obvious and crucial point: “In a free market, how much a pharmaceutical company charges for a vaccine is mainly determined by how much governments are willing to pay for it.” And there’s the rub to our dream partnership. The exclusivity that the FDA head Slaoui wants to offer could lead to price gouging underwritten by the government. (Psst, if you were clever, you might find yourself investing in Lilly and AstraZeneca stocks right now, no doubt like many a Congressperson.)

It’s clear our technology is getting to that place where we can rapidly respond to pandemics, if we choose to. What Abcellera has already accomplished, without all the details, is close to miraculous — being able to take any virus and come up with “a functionally integrated platform to deliver pandemic prevention

treatments in <60 days.” But the buck stops where the buck stops, and that may be the limit of public service expectations for Big Pharma, even in a pandemic.

Certainly, Mike Davis sees this as a limitation, as he argues in The Monster Enters, “[M]ultinational capital has been the driver of disease evolution” through our continued destruction of our habitat, and “the failure of the pharmaceutical industry to find profit in mass producing lifeline antivirals, new-generation antibiotics, and universal vaccines.” And yet, this is just what DARPA has set up with its P3 apparatus. Rapid response (ka-ching) rather than universal solutions (what are we commies? they might ask).

There appear to be legitimate reasons to be concerned with the Big Pharma companies involved with a solution to the Covid-19 pandemic. AstraZeneca and Eli Lilly, for instance, were caught up in the Iraqi oil-for-food bribery scandal that the UK’s Serious Fraud Office’s investigation was described as “one of the biggest the organisation has ever carried out.” In essence, these companies primed the well to gain exclusive access to the Iraqi marketplace.

Eli Lilly probably requires closer scrutiny than the others, with respect to motivation. They are still remembered on Capitol Hill for the political maneuvering they effected during the late night vote on the creation of national Homeland Security in December 2002, when language was inserted that removed their legal culpability for serious flaws in thimerosal, a mercury-based preservative that Lilly added to children’s vaccines that resulted so many cases of autism that Lilly was facing multiple class action suits. It turned out that

Mitch Daniels, [George W. Bush’s] White House budget director, [was] a former Lilly executive, and the company’s chairman, Sidney Taurel, was appointed just a few months [before to] President Bush’s Homeland Security Advisory Council. George Bush senior, the President’s father, was on the Lilly board in the Seventies.

God only knows what’s under the hood now, with this president in charge, but Operation Warp Speed is a bad harbinger.

One could argue that even Lilly’s Prozac regime is controversial, not only because of the drug’s checkered effectiveness and dangers, but also because its prescriptional distribution by Do-No-Harmers (snark) has seen some pundits and critics and parents and nurses and patients and LEE wonder aloud if kickbacks weren’t behind some of the pushes of the drug. A pattern is established that suggests motives that are less than the family’s reputation for philanthropic largesse — probably well-deserved.

(Still, in researching the Lilly background I admit some dismay at discovering that Eli, a colonel in the Union army during the Civil War moved down to Mississippi after the war and ran a 1200-acre cotton plantation. What’s not answered in the cleaned up accounts I’ve read is who picked the cotton? Did Eli? Or did he hire some newly “freed” slaves to work the future Che T-shirts? Seems unimportant to some people, maybe, it does shine some light on Lilly decision-making practices.)

Sure I’m jaded, but probably the mother of all conflicts of interests — also in the Bush White House — was Dick Cheney’s interests in bombing the shit out of Iraq because he very likely personally gained from it. Just before joining Bush , he was the former CEO of Halliburton, a company that’s like a pocket Marshall Plan you call onto rebuild the blasted out country that needed regime-changing for its own good. His motto: Be the Chaos. Be the Solution.™ This seems irrelevant, but actually it’s right to the point. Now, I’m not arguing that Big Pharma helped put into play Covid-19, the way Cheney was instrumental in bringing about the war crime called Operation Shock and Awe. Next thing we knew, Cheney was trying to take off the Glove. I liked that glove.

Finally, and meanwhile, the smirklesome Viking, Vladimir Putin, is already seemingly interfering with the 2020 election — brazenly offering up his Sputnik (Hmm, Sputnik, Stuxnet, Sputnik ⇒ ?) vaccine for Covid-19, as if to shore up DJ Trump’s reelection campaign. As Putin laughs his ass off, watching us struggle in humiliation as our democracy gets clowned under by our own sober version of Yeltsin (apparently, the Russians can “do stuff” too), will he ride in like a top-naked hero to offer us vaccine shots come October?

You know, so we could make it to the polls safely in November. We wouldn’t want to let Covid-19 disenfranchise folks.

John Kendall Hawkins is an American ex-pat freelancer based in Australia.  He is a former reporter for The New Bedford Standard-Times.

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