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By Lambert Strether of Corrente
I have been remiss in not covering Operation Warp Speed (OWS), the public/private partnership the Trump administration set up to develop a vaccine for Covid-19. Bloomberg described the origin and purpose of OWS back in April, in “Trump’s ‘Operation Warp Speed’ Aims to Rush Coronavirus Vaccine“:
The Trump administration is organizing a Manhattan Project-style effort to drastically cut the time needed to develop a coronavirus vaccine, with a goal of making enough doses for most Americans by year’s end.
Called “Operation Warp Speed,” the program will pull together private pharmaceutical companies, government agencies and the military to try to cut the development time for a vaccine by as much as eight months, according to two people familiar with the matter.
Vaccine development is typically slow and high risk. The project’s goal is to cut out the slow part, the people said. Operation Warp Speed will use government resources to quickly test the world’s most promising experimental vaccines in animals, then launch coordinated human clinical trials to winnow down the candidates.
The best prospective vaccines would go into wider trials at the same time mass production ramps up.
The project will cost billions of dollars, one of the people said. And it will almost certainly result in significant waste by making inoculations at scale before knowing if they’ll be safe and effective — meaning that vaccines that fail will be useless. But it could mean having doses of vaccine available for the American public by the end of this year, instead of by next summer.
The parallel development and manufacture of vaccines seems, well, innovative to me, and in a good way. Since the alternative to a vaccine is ruin, the project really shouldn’t be descibed as “wasteful.” From the HHS FAQ, “Fact Sheet: Explaining Operation Warp Speed“:
What’s the goal?
Operation Warp Speed’s goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures)…..
Who’s working on Operation Warp Speed?
OWS is a partnership among components of the Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD). OWS engages with private firms and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. It will coordinate existing HHS-wide efforts, including the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, and work by BARDA.
Sounds complicated. And today Nicholas Florko STAT News has a nice scoop, which provides the occasion for this post: He came up with the OWS org chart, in “New document reveals scope and structure of Operation Warp Speed and underscores vast military involvement.” Here it is:
In this post, I’ll pull out and comment upon the salient points of Florko’s article, focusing on institutional issues. Then I’ll do a recap of the politics of OWS, which have centered on the stock holdings of HHS Secretary Alex Azar’s Chief Advisor. (A focus on institutional issues means that general discussion of vaccine efficacy and safety is out of scope, along with other issues like the choice of OWS participants, the vaccine approval process, manufacturer liability, or delivery dates and the political implications thereof.[1] Here is a good round-up of reactions to Florko’s scoop.)
Here is Florko’s key takeaway:
The labyrinthine chart, dated July 30, shows that roughly 60 military officials — including at least four generals — are involved in the leadership of Operation Warp Speed, many of whom have never worked in health care or vaccine development. Just 29 of the roughly 90 leaders on the chart aren’t employed by the Department of Defense; most of them work for the Department of Health and Human Services and its subagencies.
Now, to be fair, given that OWS is a public-private partnership, the scientists are employed by the pharmaceutical companies, and so don’t appear on the org chart. In addition, 600 HHS officials do not appear on the org chart. Nevertheless, the military presence is dominant:
One senior federal health official told STAT he was struck by the presence of soldiers in military uniforms walking around the health department’s headquarters in downtown Washington, and said that recently he has seen more than 100 officials in the corridors wearing “Desert Storm fatigues.”
And then there are (or are not) agencies. The FDA is not on the org chart at all, necessarily so:
The Food and Drug Administration is also largely absent from the organizational chart, though that is by design. Most FDA officials are barred from participating formally in Operation Warp Speed over concerns that their involvement would conflict with their mission to impartially review eventual vaccine applications. The one major exception is Janet Woodcock, who took a temporary leave as head of FDA’s drug center to lead the initiative’s efforts on therapeutics.
And the CDC, which surely took itself out of the running when it “botched its own test development.”
The organizational chart also underscores which agencies are not as closely involved in the leadership of the effort: namely, the Centers for Disease Control and Prevention, which took a leading role in coordinating vaccine distribution for other past pandemics, like the H1N1 pandemic of 2009.
So why the dominance of the military? One reason is logistics. The Iraq War, after all, albeit from a strategic and indeed a warfighting standpoint a complete debacle, was nevertheless a logistical triumph, beginning with prepositioning materiel in the run-up to the war. Florko writes:
Though HHS Secretary Alex Azar and Defense Secretary Mark Esper are at the top [of the org chart], the two key leaders are [Moncef] Slaoui, the formal civilian leader of the project [of whom more below], and Gen. Gustave Perna, the military lead who is the chief operating officer for Operation Warp Speed.
[Perna] is a four-star Army general who previously managed virtually all of the Army’s logistics. He was even inducted into the Army’s own logistics hall of fame. He most recently served as head of Army Materiel Command, a sprawling job that handles virtually all of the Army’s equipment. The organization’s slogan is: “If a Soldier shoots it, drives it, flies it, wears it, communicates with it, or eats it — AMC provides it.”
Military officials contend that the U.S. Army excels at complex challenges — like distributing vaccines that might need to be transported at subzero temperatures.
“You know the old joke about, ‘You and what army,’ right?” said Andrew Hunter, a Defense Department expert at a Washington think tank, the Center for Strategic and International Studies. “They routinely do things that are more complex, even than this vaccine job, all the time.”
“There are quite honestly certain logistical elements of this that the CDC has never, ever been asked to do, and why not bring the best logisticians in the world into the equation?” Mango said.
However, I would urge that there is a second reason: Trust. The military is one of the few remaining trusted public institutions in America. From Gallup:
If, when it comes time to deliver the vaccine, which will be a massive and visible public effort, it’s hard to imagine a better public relations vehicle than the military. (That may not say much about the state of our body politic, but that is where we are.) Go down Gallup’s list, and you will see there is no alternative. Small business, though trusted “a great deal” (39%), is structurally incapable of delivering vaccines; the military (40%) is. From there, there’s an 18-point drop to the medical system (22%). The only alternative I can think of is Amazon (a large technology company, 14%).
There’s a good deal more information in Florko’s article, with some concrete examples of how OWS is working with the vendors, but especially about personnel, who seem competent (indeed, I have to say that Florko occasionally verges on beat sweetening).[2]
From the institutional character of OWS, let’s turn to the charges of corruption against OWS’s Moncef Slaoui, immediately beneath HHS Secretary Azar on the org chart. Pro Publica made the running with “Trump’s Vaccine Czar Refuses to Give Up Stock in Drug Company Involved in His Government Role“:
The executive, Moncef Slaoui, is the top scientist on Operation Warp Speed, the administration’s effort to develop a coronavirus vaccine in record time. Federal law requires government officials to disclose their personal finances and divest any holdings relating to their work, but Slaoui said he wouldn’t take the job under those conditions. So the administration said it’s treating him as a contractor. Contractors aren’t bound by the same ethics rules but also aren’t supposed to wield as much authority as full employees.
Slaoui agreed to sell stock worth $12 million and resign from the board of Moderna, the developer of a leading potential vaccine. But Slaoui insisted on keeping his roughly $10 million stake in his former company, GlaxoSmithKline, another contender in the Operation Warp Speed vaccine race. “I won’t leave those shares because that’s my retirement,” he has said.
(Nobody has questioned Slaoui’s technical competence; he developed a number of vaccines at GlaxoSmithKline[3].) Here is Slaoui being interviewed in Science, “Leader of U.S. vaccine push says he‘ll quit if politics trumps science“:
Q: Have you discussed with the administration the possibility of saying, ‘Let’s not ask [the FDA] for an EUA [Emergency Use Authorization] until after 3 November?’ Let’s just clear that off the deck right now, because there’s so much worry of an October surprise and something being pushed before 3 November. It’s not going to make a difference to the pandemic if there’s a vaccine on 2 November or 4 November.
A: I have to say, maybe even despite my personal political views, that I don’t think that’s right, because 1000 people die every day [from COVID-19]. If a vaccine [had evidence of safety and efficacy] on 25 October, it should be [requested] on 25 October. If it’s 17 November, it should be 17 November. If it’s 31 December, it should be 31 December.
It needs to be absolutely shielded from the politics. I cannot control what people say. The president says things, other people will say things. Trust me, there will be no EUA filed if it’s not right.
And:
Q: You also have a history of being politically active. As a university student in Belgium, you were politically active. It’s in your blood: Your father, who resisted the French occupation of Morocco, was politically active. For you to now say there’s nothing political about Operation Warp Speed? Politics is all over this. And I wonder how you deal with political decisions that you disagree with.
A: I would immediately resign if there is undue interference in this process.
Q: If you see an EUA push you don’t believe in, you’re out?
A: I’m out. I have to say there has been absolutely no interference. Despite my past, which is still my present, I am still the same person with the same values. The pandemic is much bigger than that. Before being a political person with convictions, humanity has always been my objective.
That’s Slaoui. Here are the view of Elizabeth Warren:
Warren said lawmakers need to strengthen federal ethics laws “to root out this kind of corruption.”
“It should pass the Coronavirus Oversight Recovery Ethics Act, which is a bill that I introduced in order to prohibit conflicts of interest in the federal Covid-19 response. And the first person to be fired should be Dr. Slaoui,” the Massachusetts senator said at a Senate Appropriations subcommittee hearing.
This is (as one might expect) infantile goo-gooism from Warren. Fire Slaoui in the middle of vaccine development? Really? When the country faces ruin if OWS fails? I would recommend a little basic reading to Warren: George Washington Plunkitt’s “Honest Graft and Dishonest Graft” (practiced masterfully by the respected elders of Warren’s party):
I’ve made a big fortune out of the game, and I’m gettin’ richer every day, but I’ve not gone in for dishonest graft – blackmailin’ gamblers, saloonkeepers, disorderly people, etc. – and neither has any of the men who have made big fortunes in politics.
There’s an honest graft, and I’m an example of how it works. I might sum up the whole thing by sayin’: “I seen my opportunities and I took ’em.”
Just let me explain by examples. My party’s in power in the city, and it’s goin’ to undertake a lot of public improvements. Well, I’m tipped off, say, that they’re going to layout a new park at a certain place. I see my opportunity and I take it. I go to that place and I buy up all the land I can in the neighborhood. Then the board of this or that makes its plan public, and there is a rush to get my land, which nobody cared particular for before.
Ain’t it perfectly honest to charge a good price and make a profit on my investment and foresight? of course, it is. Well, that’s honest graft.
Now, nobody is suggesting Slaoui is going even as far as Plunkett’s “honest graft.” (Hero Fauci, who ramped Gilead’s stock, is another matter entirely, and it’s odd, or not, that Warren didn’t go after him.) If the “public improvements” get built, did “honest graft” matter so very much? Given the givens?[4] And if a safe and effective vaccine is developed — and the country and its people saved from ruin — does the stock that Slaoui held onto matter so very much?
There’s little I can say in conclusion, except I’m surprised to see that OWS doesn’t seem to be shambolic, amazingly enough. I certainly hope I’m proved right! Frankly, I’ve got a bias toward action on Covid-19, so for all my qualms about Big Pharma and the military, it’s hard to see what else could have been done, given the givens.
NOTES
[1] However, from Paul Mango, HHS’ deputy chief of staff for policy: “We are weeks away, at most, a month or two away from having at least one safe and effective vaccine.” That may or may not conform to the HHS FAQ, which says that “Operation Warp Speed’s goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021.” That is, “having” a vaccine is not the same as “having initial doses available,” a month is October 28, but two months is November 28.
[2] The parallel to China is fascinating. The People’s Liberation Army played a key role in both developing a vaccine, Ad5-nCoV, and testing it on its own personnel. The vaccine is now approved for use in the general population for one year, although it’s not clear how widely it is used, or how far commercialization has been taken. “President Xi Jinping… has driven a campaign of ‘military-civil fusion’ and coronavirus has become an accelerant.”
[3] From (sorry) Wikipedia: “Slaoui spent thirty years working at GSK. During his time there, Slaoui oversaw the development of numerous vaccines, including Cervarix to prevent cervical cancer, Rotarix to prevent gastroenteritis in children, and an Ebola vaccine. He also spent 27 years researching on a malaria vaccine, Mosquirix, that was approved by the European Medicines Agency in 2015 and touted as the first in the world.” If one must have someone from Big Pharma at the helm, Slaoui seems better than the norm; recall that Big Pharms is not enthusiastic about manufacturing vaccines, because they’re not profitable enough.
[4] Like, say, private property. Yes, I know honest graft is rent!
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The Gallup poll is specious, unless the meaning of “have confidence in” is defined to the questionee. For example, I have a high confidence that Congress will do what big business wants, and a low confidence that it will do the right thing for the people it represents.
I take a lot of surveys as a way to make a little pin money. It’s fascinating to see how surveys are constructed to drive over-determined and/or mushy results. This kind of survey I encounter more regarding brands/companies, but have seen dozens in the last two months that are election-focused that ask similar ratings for politicians and public figures and institutions.
What defines ‘trust’ or ‘trustworthiness’ is rarely offered; I don’t remember a survey that included any definitions when asking this kind of question. It’s very rare that a survey will get at all granular about one’s views.
Implicit bias is everywhere in the design of market research. For no good reason whatever, ‘male’ is almost always before ‘female’, ‘white’ almost always first on the list of racial/ethnic identification. It’s unusual for any political survey to even allow the existence of choices outside the Dem/Rep mafia. It’s fascinating to watch what the servitors of our owners and masters think important, and to watch how they seek to shape thinking by the very way they frame their questions.
I love those surveys, especially the ones that ask, what concerns you most? And offer you three or four choices: such as (depending on the survey) climate change, police brutality, Trump, and transgender rights. Strangely “Dying along with the rest of the planet as a result of a thermonuclear war” is never an option.
Military, Intelligence and Big Businesses are basically interlocked in a massive Public Private Partnership. The agencies and corporations have a massive revolving door resulting in massive conflicts of interests. It is they that control government, not the elected officials.
All of these government scientists and agencies hold patents on the research they fund on the taxpayers dime and profit from the drugs and vaccines that are developed and sold. For example NIAID and HHS scientists own half of Modernas patent. They will decide if it gets approved.
The FDA vaccine advisory boards chairwoman just announced her position to work at Moderna as one of the “investigators” on the vaccine trial, 2 months after accepting the position
Yes, that’s where we are. Interestingly, China’s effort is a public private partnership as well.
From the Florko article:
Some of these vaccines require storage at temperatures like -80C until the last 24 hours, right? Calling that subzero is a bit like saying you can smelt titanium above room temperature. It sounds like an enormous logistical challenge. The US could get some slight return on that $738B DoD budget if the army is capable of meeting that logistical challenge.
Yes, that’s why I hope some dark horse small country like South Korea or Thailand comes up with a vaccine that’s a little more sane, though the image of soldiers in camo hauling around steaming containers of cryo-vaccine is photogenic.
Moncef Slaoui is being paid $1.00 for his services in OWS and will return any unused funds meant for travel, lodging and food. Additionally “In a July 30 letter to Warren and the other lawmakers, HHS said that Slaoui did not have decision-making powers that would supplant the role of a government employee.“
In regards to his conflict of interest with owning GSK stock there is this from the GSK website –
If GSK is using the J&J model of producing a COVID-19 vaccine at cost then approval of a vaccine will have little effect on the stock price. Should the value of GSK rise more than an index of other drug stocks then Slaoui has committed to donating the difference.
Finally this – Elizabeth Warren wants details of contract for Trump’s chief vaccine advisor
Welcome to 2020 Mr. Slaoui.
To be sure,and if I remember correctly, the US military had better reaction that the CDC when West Nile virus appeared in NY. The CDC seemed reluctant to acknowledge a link between a disease in birds. other mammals, and humans and it was the US military who, asked by NY zoo professionals, studied the thing.
The military is involved. Will they approach this the same way they approach procurement with parallel design, development & manufacturing? This is not “innovative”. Think about the F-35, the ICBM interceptor, the Ford class A/C carrier, the Littoral Combat Ship & the Navy’s blue color camouflaged synthetic uniform to name a few.
Parallel development & manufacturing can have a big downside such that the product doesn’t work to spec & results in a boondoggle. So, it seems to me it has a substantial capability to be “wasteful”.