New chart reveals military’s vast involvement in Operation Warp Speed
https://www.statnews.com/2020/09/28/operation-warp-speed-vast-military-involvement/

WASHINGTON — When President Trump unveiled Operation Warp Speed in May, he declared that it was “unlike anything our country has seen since the Manhattan Project.”

The initiative — to accelerate the development of Covid-19 vaccines and therapeutics — lacks the scale, and the degree of secrecy, of the effort to build the atomic bomb. But Operation Warp Speed is largely an abstraction in Washington, with little known about who works there other than its top leaders, or how it operates. Even pharmaceutical companies hoping to offer help or partnerships have labored to figure out who to contact.

Now, an organizational chart of the $10 billion initiative, obtained by STAT, reveals the fullest picture yet of Operation Warp Speed: a highly structured organization in which military personnel vastly outnumber civilian scientists.

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.

Operation Warp Speed’s central goal is to develop, produce, and distribute 300 million doses of a coronavirus vaccine by January — and the military is intimately involved, according to Paul Mango, HHS’ deputy chief of staff for policy. It has already helped prop up more than two dozen vaccine manufacturing facilities — flying in equipment and raw materials from all over the world. It has also set up significant cybersecurity and physical security operations to ensure an eventual vaccine is guarded very closely from “state actors who don’t want us to be successful in this,” he said, adding that many of the Warp Speed discussions take place in protected rooms used to discuss classified information.

“This is a massive scientific and logistical undertaking,” said Mango. “We are weeks away, at most, a month or two away from having at least one safe and effective vaccine.”

Despite the military’s dominance, the chart also includes Nancy Messonnier, the director of the CDC’s National Center for Immunization and Respiratory Diseases who was almost fired by Trump in February for warning the public about the growing Covid-19 pandemic. Public health and drug industry officials told STAT that Messonnier and Gen. Paul Ostrowski, her direct superior, serve as the initiative’s main contacts on all questions related to the distribution of an eventual vaccine. One public health official said that Ostrowksi, an expert on military acquisition, defers to Messonnier on matters of public health.

The military’s extensive involvement in the development and distribution of a vaccine is a departure from pandemics of the past, but it is fitting for Trump, who has gushed about his love for “my military” and “my generals.” While the military was tangentially involved in public health crises like the H1N1 pandemic of 2009, some public health leaders have raised concerns about what they see as their marginalization during the pandemic.

Related: The 8 most important leaders of Operation Warp Speed
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.”

“Military personnel won’t be familiar with the health resources available in a community,” said John Auerbach, CEO of Trust for America’s Health, a group closely aligned with public health departments. “They don’t know who the doctors are or where the community health centers are located or what resources they have. They don’t know where the pharmacies are. Public health people do know, that’s part of what they do.”

Operation Warp Speed chart

The July 30 Operation Warp Speed organizational chart obtained by STAT details about 90 of the officials involved in the initiative. Roughly 60 work for the Department of Defense.

Military officials, however, 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.”

Mango told STAT the operation has kept some key personnel information under wraps out of concerns for the security of the entire vaccine supply chain, from the warehouses storing vaccines to the computer systems being used to coordinate the effort.

“The secretary has given us the order of being as transparent as we possibly can with one caveat: That we are not compromising anything that has to do with national security,” he said.

An HHS spokesperson declined to comment directly on the chart, citing precedent that the agency does not comment on leaked documents. But the spokesperson noted that at least 600 HHS officials are involved in Warp Speed. The majority of those employees are not captured by the chart obtained by STAT. Among the decision makers not included in the chart are Mango and HHS’ Assistant Secretary for Preparedness and Response, Bob Kadlec. Mango told STAT that he and Kadlec personally sign off on every business agreement made by HHS for Operation Warp Speed.

Mango also added that the vast majority of scientists working on Operation Warp Speed work for the companies the effort is funding.

“There’s really not a need for anyone to place scores of scientists inside HHS or DOD to get this done,” Mango said. “Quite honestly, we are not conducting any science whatsoever inside the government to support Operation Warp Speed, none.”

He also defended the military’s involvement in the initiative, though he insisted that it is primarily supporting efforts led by public health officials at the CDC.

“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.

Beyond obtaining the internal document from a federal official, STAT interviewed companies funded by Warp Speed and more than a dozen key officials who have worked closely with the organization’s leaders. The reporting sheds light on the high degree of organization and specialization within the organization, as well as the extreme demands the initiative is placing on the companies it funds.

Operation Warp Speed’s central goal is to develop, produce, and distribute 300 million doses of a coronavirus vaccine by January. The initiative has poured $10 billion into the clinical development and manufacturing of potential vaccine candidates, and it has stockpiled hundreds of thousands of doses of as-yet-unproven immunizations. Warp Speed has deals with six major drug companies hoping to develop Covid-19 vaccines and may seek more, the group’s chief adviser, Moncef Slaoui, told STAT earlier this month.

Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases, approvingly called Operation Warp Speed a “talent show.”

“If you go through the organizational boxes of Operation Warp Speed, they’re very, very impressive,” Fauci told STAT in an interview Friday.

Tom Inglesby, the director of the Johns Hopkins Center for Health Security, with whom STAT shared the organizational chart, agreed that the initiative appears well-positioned to achieve its ambitious goals — and under a tight timeline.

“There is deep knowledge of science and on how to manage complex government operations,” said Inglesby. “It’s clearly operating in a challenging pandemic and political environment, and we won’t know if we have a safe and effective vaccine until the trials are finished. But it’s a highly competent group of people working to make it happen.”

Though HHS Secretary Alex Azar and Defense Secretary Mark Esper are at the top, the two key leaders are Slaoui, the formal civilian leader of the project, and Gen. Gustave Perna, the military lead who is the chief operating officer for Operation Warp Speed.

Under Slaoui are two major pillars, “Vaccine” and “Therapeutics.” Under Perna are three pillars, for “Plans, Ops and Analysis,” “Security and Assurance,” and “Supply, Production and [Distribution].”

But the complexity of the organization makes it difficult as an outsider to discern who is reporting directly to who, experts in business management who reviewed the chart told STAT.

“It’s confusing for sure,” said Robert Huckman, the chair of Harvard Business School’s health care initiative, who studies health care management and organization. Huckman added that the chart was more complex than most he’s seen. “It is more complex, but it’s a more complex endeavor, too … it may be that it simply reflects the complexity of what Operation Warp Speed is trying to do.”

“I can only imagine the headache that comes with trying to coordinate these different production processes,” said Raffaella Sadun, a professor of business administration at Harvard Business School who studies CEO behavior.

Slaoui’s tenure thus far at Warp Speed has been marked by outside concerns over his personal financial stake in some of the companies he is now overseeing. Slaoui, who holds roughly $10 million in GSK stock, is not bound by federal ethics rules because he is employed by an outside contractor, not the federal government. Slaoui has agreed to donate any increase in the value of that stock, although that agreement hasn’t placated critics.

“The first person to be fired should be Dr. Slaoui,” Sen. Elizabeth Warren (D-Mass.) said at a hearing last week. “The American people deserve to know that Covid-19 vaccine decisions are based on science, and not on personal greed.”

Related: Operation Warp Speed promised to do the impossible. How far has it come?
But Slaoui knows firsthand, perhaps better than anyone else, what it takes to dramatically speed up the search for a vaccine. He played a pivotal role in GSK’s sprint to develop an Ebola vaccine in 2015. The effort ultimately failed, but he is so well-regarded at GSK that the company named its vaccine research center after him in 2016.

Perna, meanwhile, 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.”

During his tenure, Perna constantly pushed the Army to move faster, and to be more ready to go to war at a moment’s notice.

Below Perna and Slaoui are a team of military and civilian experts like Ostrowski, a former special forces soldier who handles the supply and distribution of an eventual vaccine, and Matt Hepburn, the initiative’s go-to vaccine coordinator. Hepburn cut his teeth working on high-tech military projects, including an initiative that developed sensors that could be implanted into soldiers to detect certain illnesses before the men and women ever showed symptoms. Hepburn also has a reputation for driving even the most accomplished scientists to work harder than they’ve ever worked before.

“If Matt is still the Matt I know, he will be on these people with a foot on their neck, making them go go go,” said Geoffrey Ling, Hepburn’s former boss at the Defense Advanced Research Projects Agency.

Related: Operation Warp Speed doesn’t have the transparency it needs
There are government outsiders deeply involved in the project, too. Larry Corey, one of the country’s leading AIDS researchers, describes himself as an “ex-officio” member of Warp Speed. Corey runs the Covid-19 prevention network, an assortment of existing HIV trial networks that now are running at least three of the Phase 3 Covid-19 clinical trials. While he’s not formally on the organizational chart, he takes part in thrice-weekly calls with Warp Speed. Corey, who is based in Seattle, is in constant cross-country coordination with one of the NIH’s top vaccine researchers, John Mascola, a formal member of the organization.

“We are sacrificing our time and energy on Operation Warp Speed. We have taken the pivot from everything else that we have done in our lives,” Corey said, regarding him and Mascola. Corey described waking up at 5 a.m. each day to get on calls with Warp Speed leaders at 5:30 a.m., and then enduring a deluge of conference calls until 6 p.m. When the day’s work is done, he turns to planning for the following day, which keeps him working until 11 p.m. He’s in bed by midnight.

“I don’t think his day is any different than my day,” Corey said of Mascola. Both, he was sure, are sleep-deprived.

Operation Warp Speed is much more than a splashy name for an initiative focused on doling out purchase orders. The benefits for companies who land a Warp Speed contract go far beyond just money, according to one of the companies with a contract.

SiO2 Materials Science, an Auburn, Ala.-based company that is making vials for the effort, used its status as an Operation Warp Speed grantee to force a vendor to cut production time from 75 days to just seven. It also leveraged its contract with Warp Speed to get its power turned on in the midst of a massive outage in just minutes — others had to wait days, according Lawrence Ganti, the company’s chief business officer. Operation Warp Speed also covered the costs of installing 32 new security cameras around the company’s facility after an assessment found the company’s physical security was lacking.

SiO2 received $143 million from Operation Warp Speed, a fraction of what larger companies have received, but the company still is required to provide monthly status reports to the government. The reports typically run up to 60 pages and are coupled with a four-hour meeting attended by multiple Warp Speed officials, according to Ganti. That’s in addition to biweekly “risk reports” and weekly site visits from the Army Corps of Engineers.

A second company funded by Warp Speed confirmed similar reporting requirements.

“Everybody has — or at least I had a stereotype of how the government operated. Nine-to-five, slow, kind of what you’d expect at the DMV … this is not that in any way,” said Ganti. “They seem to be working 24/7.”

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. There are at least three staffers from each of the administration’s other major health agencies, like the Biomedical Advanced Research and Development Authority or the National Institutes of Health.

Mango, the HHS deputy chief of staff, said the CDC has a more central role than the personnel chart implies. He personally interacts with Messonier multiple times a week, and there are frequent meetings between the DOD and CDC with 15-20 of her deputies, he said.

“What General Perna says at the start of every meeting, and he means it, is we are here for one reason, to support the CDC,” Mango said. “Anyone who is watching what is going on a daily basis would say the CDC is leading and the DOD is enabling and supporting.”

Chief Pentagon Spokesperson Jonathan Hoffman struck a similar tone.

“The Department of Defense has been clear in its role in Operation Warp Speed: We are providing the bandwidth of logistical expertise, including program management and contracting proficiency to this all-of-America effort,” he said in a statement. “The development and delivery of over 300 million vaccine doses harnesses public-private partnerships, academia, and industry – no one entity can do this alone.”

The Pentagon also declined to comment on the chart obtained by STAT, saying they do not comment on leaked documents.

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.

BARDA plays perhaps the most head-scratching role in Operation Warp Speed. The organization’s acting director, Gary Disbrow, a camera-shy bureaucrat who was catapulted into the job after the ouster of his boss, Rick Bright, is listed as co-leading the vaccine effort alongside Hepburn, and a number of other BARDA leaders are included in the chart.

But three sources told STAT that Disbrow, and BARDA more generally, are playing a marginal role in Warp Speed. “BARDA has been largely sidelined in all of this,” one pharmaceutical industry source told STAT.

Ganti of SiO2, however, told STAT that the company deals primarily with BARDA for all of its Warp Speed-related questions. Mango also told STAT BARDA officials meet with Warp Speed officials daily “to make sure contracts are moving along.”

BARDA also appears to be fronting a large chunk of the funding for the Warp Speed initiative, alongside the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.

Operation Warp Speed doesn't have the transparency it needs
https://www.statnews.com/2020/07/16/moncef-slaoui-operation-warp-speed/

The Scary New Contracting Model That Isn’t Scary or New - Nextgov
https://www.nextgov.com/it-modernization/2018/03/otas-scary-new-contracting-model-isnt-scary-or-new/146964/

MARCH 26, 2018
“Other Transaction Authorities” might seem like a risky new acquisition method, but it’s been around longer than the Federal Acquisition Regulation.
PROCUREMENT
INNOVATION
HOMELAND SECURITY
This is part of a series about other transaction authority. Read the role of consortia and what agencies are buying.

There is a new and scary but potentially game-changing acquisition model catching fire across government. The thing is, it doesn’t have to be scary and is not really all that new.

Long lead times and complex, overwrought requirements have made acquisition one of the main impediments to successful information technology procurements in the federal government, resulting in no shortage of handwringing over the rules included in the Federal Acquisition Regulation that govern most transactions. But there is another way, if program managers, contracting officials and agency lawyers are willing to take a chance.

Before there was a FAR, there were “other transaction authorities,” also known by the shorthand OTAs or OTs. This contracting method outside the usual federal process is not widely used and even less understood. But that’s beginning to change.

“Is there anything here to be worried about? No,” Douglas Maughan, director of the Homeland Security Department's Science and Technology Directorate’s Cyber Security Division, told Nextgov. “Even though it’s been around for a fairly lengthy period of time, it’s just not been used very much. So, people are afraid of it because they haven’t seen how it’s worked.”

‘Or Other Transactions…’

When NASA was founded in 1958, Paul Dembling, then-general counsel for the agency’s predecessor, the National Advisory Committee for Aeronautics, wrote a section into the Space Act describing the agency’s acquisition authority.

The legislation allowed NASA “to enter into and perform such contracts, leases, cooperative agreements or other transactions as may be necessary in the conduct of its work.”

“This was 1958 and NASA was a big deal,” said Ralph Nash, a government procurement law expert and founder of the Government Contracts Program at George Washington University’s National Law Center, where he is a former dean of graduate studies and professor emeritus.

“We were in a space race with the Russians and President [John] Kennedy said we would get to the moon in this decade,” he explained. “This was there to give them full flexibility.”

Three decades later—well after the establishment of the FAR—that same language was used to grant the Defense Department similar authorities.

Congress gave Defense contracting officials the tool in 1989 with the express goal of helping non-traditional—or at least not frequent—contractors to research new technologies alongside the department.

By 1994, that authority had been broadened beyond research to include prototyping and then updated again in 2017 to enable contracts to move into production after successful prototypes.

Over that time, several departments have been granted other transaction authorities, including Defense, Energy, Health and Human Services, Homeland Security and Transportation. Under these departments, five component agencies have also been given explicit OT authority: the Federal Aviation Administration, Transportation Security Administration, National Institutes of Health, Domestic Nuclear Detection Office and Advanced Research Projects Agency-Energy, or ARPA-E.

“Under these authorities, agencies may develop agreements that are not required to follow a standard format or include terms and conditions that are typically required when using traditional mechanisms,” according to a Government Accountability Office definition.

The Wild West of Procurement?

Homeland Security’s Science and Technology Directorate awarded its first OT contract for cybersecurity in February 2016 after launching its Silicon Valley Innovation program.

The directorate started the Silicon Valley program to “reach out to…non-traditional performers—the perfect example of what a startup is,” Maughan explained. “What we’re trying to do in the Silicon Valley program is, in partnership with components as well as critical infrastructure providers, we’re looking for early-stage companies that have technology that we could use to bring capability to our components or first responders or the private sector.”

That sparked the first broad agency announcement call in December 2015 seeking interesting applications of the internet of things to support first responders and secure critical infrastructure.

Those calls have continued, with S&T awarding 37 OT contracts in 2017. In total, the directorate has worked with 25 companies through the Silicon Valley program.

While the primary focus for OTs is on research and development, not all agencies are using them for that express purpose. For instance, TSA and NASA use them for other services, such as airport security, education and outreach, according to GAO.

Broadening OTs beyond research seems to increase their use accordingly. GAO reports that while most agencies do fewer than 75 OT transactions a year, TSA and NASA conducted 640 and 3,220, respectively, in 2014 alone.

Many in government have been reluctant to use their OT authorities precisely because of the lack of regulations governing their use. Since the contracts exist outside of the Federal Acquisition Regulation, they can be written with far less stringent requirements. But that also means there are fewer protections along the way to avoid a catastrophic contracting failure—one that could land a government official in front of a congressional committee.

But just because there aren’t as many regulations doesn’t mean there isn’t oversight, Maughan said.

“It depends on your definition of oversight,” he said. “Even though it’s not FAR-based, we still have to do procurement documentation, we have to do a source-selection plan that says what are the criteria by which we’re going to evaluate proposals. For the most part, it’s the same as a traditional FAR-based contract, it’s just that the vehicle you’re using is not a FAR-based vehicle.”

Despite appearances, “It’s not the wild, wild west,” Maughan added. “You still have to make sure the government is making the decisions on what gets awarded. Even still, we have a contracting officer—who’s called an ‘other transaction authority officer’—so you’re still doing the same kinds of things with the contracting folks as part of the team.”

Funding Failure

The reluctance to use OTs is based on “fear of giving people a lot of discretion,” said Nash, the procurement law expert. “If you’re in a government agency and you’ve got an inspector general and you’ve got congressional oversight … there’s a tendency to be pretty cautious about how you do business.”

That said, “It’s the same oversight you have over any other transaction where you’re giving a company money,” Nash said. “The problem is, if you have a lot of discretion, you take away a lot of the rules, but you still have basic ethics problems. If you gave an OT to your father without telling anybody else about it, you’d have the same ethical violation you’d have with a contract or a grant.”

The other major roadblock is the fear of funding projects that don't pan out, Nash said.

“People have a hard time understanding that when you fund research, over half the time you’re funding failure,” Nash said. “You do not get 100 percent payout from research; and you shouldn’t expect it.” If you were to see a 100 percent success rate in funding research, that would just mean you weren't looking far enough into the future.

“There’s nothing wrong with failure,” Nash said.

Homeland Security’s Maughan agreed. “We have a lot of successes we can talk about with return on investment, but even the failures” have some return, he said. He cited a program to downsize a Defense Department radar system to fit on smaller drones used by U.S. Customs and Border Protection. The company awarded a contract ultimately failed to produce a working prototype, but everyone involved still consider it a successful venture.

The company was able to get funding to move their research forward and CBP learned what is feasible for the size of drones they use. “They were still really happy about being part of the program,” Maughan said. “We helped them move the technology down the roadmap toward a smaller device and that will help them in some of their DOD missions.”

“I think there’s still some return on investment," he added. "Our investment was less than $400,000 with them, so I think it falls into the category of: If you’re going to fail, fail quickly."

Had the office used a traditional contracting method for this project, it likely would have taken six to 12 months just to make an award, let alone discover that the idea would not work. Under the Science and Technology Directorate's OT authority, the time from application to award can be as short as 60 to 90 days.

Is It Worth It?

Overall, Maughan said he would recommend using OT contracts when appropriate but advised contracting officers to pick the right spots.

“It’s not a solution for every case,” he said. “If you’re trying to get startups with new innovation, then an OT might be good for you as an organization. There’s a little bit of risk working with a startup company—if you’re really just looking for a solutions provider and you’re not willing to take some risk, then an OT might not be for you.”

“It’s not the answer for all things,” he added.

Nash agreed and offered some advice to agencies interested in getting in on OTs.

“Let’s say you find a company out there that’s never done business with the government and that has some fascinating technology. You go to them and you say, ‘How could we sponsor you to do this? And we’ll give you all the money.’ Well, they may say, ‘The only way we’ll deal with you is this, this, this and this,’” Nash said. “We’re talking about intellectual property issues; we’re talking about accounting issues. And a normal contracting office might be pretty darn uncomfortable when they hear that because that’s not their norm.”

“You’ve got accounting problems. You want to make sure the company spends the money for what you gave them the money,” which can be particularly difficult, as one advantage of an OT contract is the company does not have to abide by government accounting standards. “But you need to make sure they have some systems.

“You need to worry about intellectual property—who’s going to have rights to it. And that would mean that if they said, ‘We’ll only do it if you take zero rights,’ that would be a problem. You might do it but you certainly would know that that’s a flashpoint that you would worry about. And then, of course, you’ve got to worry about audit rights because the government always wants to be able to audit and the contractor might not want to be audited.”

But these issues wouldn’t be news to a contracting officer who has spent any amount of time working in government, Nash said.

“The problem, I think, is, will your contracting office be willing to step outside of its normal FAR logic and really make it wide open?”

Public Readiness and Emergency Preparedness Act
https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims:

of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions
determined by the Secretary to constitute a present, or credible risk of a future public health emergency
to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures

Advanced Technology International (ATI) - ATI | Advanced Technology International
https://web.archive.org/web/20220301220542/https://www.ati.org/

REDUCING BARRIERS TO ENTRY
BENEFITS TO INDUSTRY & ACADEMIA
We help non-traditional contractors – including small businesses, start-ups, and academia – get involved in government contracting. In fact, non-traditional contractors account for about 75 percent of ATI’s consortia membership, and they receive about 60 percent of awards. The government benefits by getting access to emerging technologies, and these non-traditional contractors benefit from:

Funding
Exposure
Networking
Experience
Future connections

Other Transaction Agreements (OTA) – ATI | Advanced Technology International
https://web.archive.org/web/20210401134551/https://www.ati.org/ota/

ATI has extensive experience and expertise in the Other Transaction consortium business model.
Other Transaction Agreements (OTA), relieve some of the contractual burdens typically placed on contractors working for federal clients, making it possible for non-traditional contractors – small and emerging companies – to participate in technology development.

The Other Transaction (OT) consortium model is an “enterprise partnership” between the government and technology providers in a specific domain. The OT consortium model relieves some of the contractual burdens typically placed on contractors working for federal clients.

We have extensive experience and expertise in OTA collaboration management. Our successful application of the OTA consortium model has played a major role in the growth of its popularity, and we remain the industry leader in this area.

Other Transaction Authority (OTA) | AiDA
https://aida.mitre.org/ota/

What is an “Other Transaction”
Other Transactions (OTs) are procurement instruments other than contracts, grants, or cooperative agreements enabling flexible business arrangements to acquire research and development to support technology advancement or to quickly develop a prototype. Many laws and regulations governing federal contracts do not apply to OTs (i.e., Federal Acquisition Regulation (FAR) and the Competition in Contracting Act (CICA)), however, the Procurement Integrity Act applies and competitive practices are applicable. OTs may be protested to the U.S. Court of Federal Claims, and GAO has limited jurisdiction to review OT decisions. GAO ruled on proper use of an OT in these cases: GAO B-416061 and GAO B-416752.

OTs are a mechanism to access innovative research and development, especially from *non-traditional contractors who may be challenged by requirements of traditional contracts, grants, or cooperative research and development agreements. OTs can be used with traditional contractors when statutory requirements are met. OTs provide flexibility that allows for increased speed, flexibility, and accessibility for research and prototyping activities than permitted under statutes and regulations that apply to traditional FAR-based contracts. OT agreements may be fixed-price, expenditure based, or hybrid.

https://crsreports.congress.gov/product/pdf/R/R45521

OTs have the potential to provide significant benefits to DOD, including
 attracting nontraditional contractors with promising technological capabilities to work with DOD,
 establishing a mechanism to pool resources with other entities to facilitate development of, and
obtain, state-of-the-art dual-use technologies, and
 offering a unique mechanism for DOD to invest in, and influence the direction of, technology
development

...

A number of analysts and officials have raised concerns that if DOD uses OTs in ways not intended by
Congress—or is perceived to abuse the authority—Congress could clamp down on the authority. Generally, DOD
lacks authoritative data that can be used to measure and evaluate the use of other transaction authorities.

...

Issues for Congress
How Far Should OT Authority Extend?

...

Given the benefits
and risks associated with OTs, questions for Congress include the following:
1. To what extent and in what circumstances do the potential benefits of OTs in
terms of cost, schedule, and added capabilities outweigh concerns over potential
fraud, waste, abuse, diminished oversight, and other public policy objectives?
2. Should OT authorities be extended further, curtailed, or maintained?

Medical Countermeasures | USA Public Health Security
https://www.medicalcountermeasures.gov/newsroom/2020/pfizer/

The U.S. Department of Health and Human Services and the Department of Defense (DoD) today announced an agreement with U.S.-based Pfizer Inc.

Medical Countermeasures | USA Public Health Security
https://www.medicalcountermeasures.gov/newsroom/2020/pfizer-1/

About Operation Warp Speed:

OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

Military’s Role in Vaccine to Be Strictly Behind the Scenes - The New York Times
https://www.nytimes.com/2020/11/26/us/politics/coronavirus-vaccine-military-trump.html?

Scores of Defense Department employees are laced through the government offices involved in the effort, making up a large portion of the federal personnel devoted to the effort. Those numbers have led some current and former officials at the Centers for Disease Control and Prevention to privately grumble that the military’s role in Operation Warp Speed was too large for a task that is, at its core, a public health campaign.

“I was surprised when Trump talked about the Department of Defense disseminating any vaccine,” said Dr. Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, which has been deeply involved in the planning process for the vaccines. “There is not any role for the military there. And if there were, we would be up in arms about it because we are advocates for the states.”

Concerns about conspiracy theories surrounding the vaccines are even more reason to keep the military out of sight, Dr. Plescia said.
“There has been a lot of concern around vaccine hesitancy, and having a bunch of troops around would not be very helpful,” he said.



https://www.washingtonpost.com/national-security/how-a-secretive-pentagon-agency-seeded-the-ground-for-a-rapid-coronavirus-cure/2020/07/30/ad1853c4-c778-11ea-a9d3-74640f25b953_story.html

July 31, 2020 at 3:22 a.m. GMT+2
The scientists were working through the night over a weekend in February in their Vancouver offices, running a blood sample from an early American covid-19 survivor through a credit card-sized device made up of 200,000 tiny chambers, hoping to help save the world.

Their mission was part of a program under the Pentagon’s secretive technology research agency. The goal: to find a way to produce antibodies for any virus in the world within 60 days of collecting a blood sample from a survivor.

Established years before the current pandemic, the program was halfway done when the first case of the novel coronavirus arrived in the United States early this year. But everyone involved in the effort by the Defense Advanced Research Projects Agency (DARPA) knew their time had come ahead of schedule.

The four teams participating in the program abandoned their plans and began sprinting, separately, toward the development of an antibody for covid-19, the disease caused by the coronavirus.

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“We have been thinking about and preparing for this for a long time, and it’s almost a bit surreal,” said Amy Jenkins, manager of DARPA’s antibody program, which is known as the Pandemic Prevention Platform, or P3. “We are very hopeful that we will at least be able to have an impact on this outbreak. We want to make a difference.”

In that program and others, DARPA has quietly been seeding the ground for the United States to produce a rapid cure for a pathogen like covid-19 for years.

The U.S. government’s response to the pandemic has been impugned as slow and haphazard, with flawed test kits, limited contact tracing, insufficient protective gear, late encouragement of masks and at times baffling messages from President Trump.

But DARPA’s story is a counterexample of U.S. government foresight, one that began more than a decade ago with the aim of finding super-fast ways to protect American troops if they were to confront a deadly new virus in the field.

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If it weren’t for DARPA’s investments over the past decade and earlier, largely outside the glare of Washington’s partisan politics, the American race toward a vaccine and antibody therapy to stop the coronavirus most likely wouldn’t be moving as quickly as it is today.

“Being at DARPA at this time ... is exciting in some ways because we get to see the research work that was funded that was done ten to fifteen years ago now really starting to pay off,” acting director Peter Highnam said in a discussion with reporters on Thursday.

The first company in the United States to enter clinical trials with a vaccine for the virus was funded by DARPA. So was the second company. And the P3 program has already led to the world’s first study in humans of a potential covid-19 antibody treatment. If successful, antibody treatments would offer up to three months of immunity against covid-19. Unlike vaccines, they could also help heal people already infected with the virus.

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Some of the vaccines and antibodies linked to DARPA could be ready later this year, which would mark one of the speediest responses to a global pandemic in the history of medicine. Experts say it normally takes four to 10 years to devise, test and produce a vaccine for a new pathogen. Antibodies, which the body creates to combat a virus, have taken years to discover, let alone produce.

The race for a coronavirus vaccine could lead to this generation’s Sputnik moment

DARPA is far from exclusively responsible for the fast pace. Other countries, including China, where the virus originated, are also moving quickly toward a cure. So are firms unaffiliated with DARPA.

Still, the Pentagon agency played a significant role in advancing the science that is making the quick pace possible and setting a North Star for researchers.

“I think their role is very important,” said James E. Crowe Jr., director of the vaccine center at Vanderbilt University, one of the four participants in the P3 program. “The reason is they have catalyzed more rapid progression than otherwise would have happened. And the reason they accomplished it was they were willing to state . . . grand challenges.”

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Crowe said he and his colleagues laughed when DARPA put out its request in 2017 for a system that could produce a human-ready antibody from a convalescent blood sample in 60 days.

“Somehow, in setting that aspirational goal, after the first brainstem reaction of, ‘That’s ridiculous,’ the next step is, ‘Well, how close could we get?’ ” Crowe said. “Then, you start buying in to the belief that it could be possible.”

'Ringing people's doorbells'
Established in 1958 in response to the Soviet Union’s launch of Sputnik, DARPA was created by President Dwight D. Eisenhower out of a sense of urgency.

Washington could have sent the first satellite to space, but Moscow got there first — and it wasn’t because the United States lacked the science. The American government simply didn’t move fast enough.

DARPA was the answer to that problem.

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The nimble military science research agency wouldn’t invent things itself. Rather, its officials would look across the American scientific landscape — to universities, military labs and defense contractors — and channel emerging technologies into risky mega-endeavors to prevent another Sputnik. The agency’s pie-in-the-sky projects would have a high risk of failure, but if successful, would transform the U.S. military and possibly society, too.

Over the years, DARPA-funded projects have created the building blocks of GPS, the first computer mouse and the protocols that underpin the modern Internet. The agency pioneered stealth technology that made American fighter jets all but invisible to enemy radar. And it advanced a bevy of new weaponry, including drones.

How the audacious Pentagon agency that invented the Internet is now trying to save it

In the years after the attacks of Sept. 11, 2001, a series of anthrax incidents, combined with overseas intelligence about potential biological threats, heightened fears of bioterrorism and drove DARPA to invest in faster ways to respond, including technology to accelerate vaccine development, spot emerging viruses and speed up pharmaceutical manufacturing.

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A decade ago, a brainy Air Force doctor named Dan Wattendorf helped push rapid pandemic response further to the top of DARPA’s priority list.

Regularly citing the 1918 flu pandemic, the DARPA program manager saw how a novel pathogen, whether from another species or an enemy’s lab, could cripple the American military in the field.

“If we need to deploy someone in harm’s way and it’s a new virus, you don’t have time to wait for a new vaccine,” Wattendorf said. “That could be a decade.”

Wattendorf had ideas for a solution. In 2010, he took to a conference room at DARPA headquarters in Northern Virginia with notes scribbled on his hand to make a pitch.

At the time, the Obama administration was emphasizing the need to step up pandemic response capabilities in the wake of the H1N1 outbreak, and DARPA was increasingly focusing on biology — an emphasis that would lead to the agency’s first biotechnology office in 2014.

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In the conference room, Wattendorf outlined his ideas to agency higher-ups. Regina E. Dugan, the DARPA director at the time, ribbed him for the writing on his hand before greenlighting his proposal.

The result was a program called ADEPT, which invested $291 million from 2011 to 2019 in an array of technologies — including a credit card-sized device for rapid antibody discovery developed by the Vancouver-based firm AbCellera — that, taken together, could significantly reduce the timelines for vaccines and antibodies.

“It may turn out to be the most important program from my time at the agency,” said Dugan, who ran DARPA from 2009 to 2012.

Chief among Wattendorf’s targets for the program: delivering vaccines and antibodies by implanting their genetic code.

Traditional vaccines inject what’s known as an antigen — usually a piece of live or deactivated virus that is sufficient to provoke the immune system into a protective response. Antigens are typically manufactured in a long process that involves growing live virus in chicken eggs in bioreactors.

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Wattendorf hoped to short-circuit it. He wanted to inject genetic code that would prompt the human body to create the antigen in its own cells, cutting out the manufacturing process. The immune system would recognize the antigen in the cells and launch a protective response.

By 2010, scientists had tested the idea using DNA with mixed results. Wattendorf wanted to try its single-stranded sibling RNA.

If successful, RNA could be used to develop both vaccines and antibodies, shortening development timelines from years to days before clinical trials, he thought. It also offered a one-size-fits-all approach; in the future, scientists would need only the genetic code of a virus to create a vaccine.

At the time, many considered it a fool’s errand. Being so ephemeral, RNA is unstable in the environment and highly susceptible to degradation. It was unclear how to get it into a human cell. Over at the National Institutes of Health, where Wattendorf previously worked, research into DNA vaccines was presenting enough hurdles. Few wanted to take the risk of trying RNA, too.

“Skeptics cited the lack of evidence that it would work, and Dan cited the lack of evidence that it wouldn’t,” Dugan recalled. “That’s very typical of a DARPA program.”

By 2019, a project DARPA funded at the Massachusetts-based company Moderna demonstrated in a Phase 1 clinical trial that RNA could indeed deliver an antibody to humans and provide protection against the mosquito-borne virus chikungunya. It was an affirmation of Wattendorf’s bet that came after years of DARPA funding the effort.

Today, RNA vaccines, although still experimental, are among the fastest-moving candidates in the race to stop covid-19. In March, Moderna was the first company in the United States to enter Phase 1 trials with a covid-1 vaccine using RNA. The company injected its first test into a human 66 days after receiving the virus’s genetic code. Phase 2 trials began in May, and Phase 3 began on July 27, making it possible that the vaccine could be available by the end of the year.

In addition to Moderna, two other pharmaceutical companies — Pfizer and CureVac — are pursuing RNA vaccines, as is a small laboratory at Imperial College in London and the People’s Liberation Army Academy of Military Sciences in China. CureVac was also funded by DARPA.

RNA experiments leap to the front in coronavirus vaccine race. Will they work?

“Is an RNA vaccine going to potentially be made available at scale?” Wattendorf said. “We are seeing very well that could happen. It demonstrates the role DARPA can play in creating these capabilities.”

Wattendorf also continued DARPA investments in vaccines delivered using DNA.

Inovio Pharmaceuticals, funded by DARPA, entered Phase 1 trials for its DNA-delivered covid-19 vaccine in April, making it the second company to enter trials in the United States. The Pennsylvania-based firm, which began trials 80 days after receiving the virus’s genetic code, is looking to begin its Phase 2 and 3 trials this summer, pending regulatory approval.

DARPA also funded other technologies for rapid vaccine development, including companies that manufacture vaccines by growing proteins in tobacco-like plants, as well as a “self-assembling vaccine” platform at Massachusetts General Hospital. Mass General’s vaccine center used the platform to develop a more traditional covid-19 vaccine that entered animal testing in early July.

“DARPA comes off as a visionary organization that was ringing people’s doorbells and saying you have to prepare for this,” said Mark C. Poznansky, director of the Mass General Vaccine and Immunotherapy Center. “Some people would say we have enough to worry about without that.”

'The more aspirational dream'
From the start, Wattendorf and the DARPA team knew that fast vaccines on their own wouldn’t solve the threat that infectious diseases posed to American troops.

It can take weeks for a vaccine to give a person protection, and even then, follow-up booster shots are sometimes needed.

Instead of forcing the body to produce antibodies using a vaccine, why not just inject the best antibody directly? The DARPA team began to pursue that aim in parallel. Wattendorf called the rapid delivery of an antibody using RNA “the more aspirational dream.”

The idea was to take the blood of a virus survivor and quickly identify the best antibody out of thousands in the bloodstream. Then, the genetic code of that antibody could be injected into troops to give them temporary protection against the virus immediately. Protection could range from a few weeks to a few months — enough time for a deployment.

In a pandemic, DARPA envisioned using such antibodies as a “firebreak” — an obstacle that slows the rapid spread of a conflagration.

For example, if one person in a nursing home tests positive, the antibody could be given to all the other residents to prevent the spread of the illness.

Critically, unlike vaccines, antibodies can also treat those who have already fallen ill.

DARPA had funded the development of rapid antibody technologies for years. Then, around 2016, DARPA Director Arati Prabhakar wanted to weave them together into a production line and test it.

“Very few interesting problems just have a miracle, single-threaded solution,” Prabhakar said.

The result was the Pandemic Prevention Platform, which Prabhakar signed off on before leaving DARPA in January 2017. The goal of the four-year $96 million program was to develop an antibody for any virus within 60 days of receiving the blood sample of a survivor.

When covid-19 arrived in the United States, the program’s participants — AbCellera, Vanderbilt University, Duke University and AstraZeneca — had already done test runs with various viruses to see where they could cut time on their quest to hit the 60-day goal.

As they pivoted to tackle covid-19, Jenkins, the DARPA program manager, knew the participants wouldn’t meet the 60-day timeline but thought some could come close to 90 days, and potentially help end the global pandemic.

Some of the participants obtained a blood sample in February from one of the first American covid-19 patients to return from China. But the sample wasn’t great; the patient had recovered fairly recently and therefore didn’t have a sufficiently mature immune response from which to draw good antibodies.

At AbCellera, chief executive Carl Hansen forged ahead with the sample anyway.

On Feb. 28, AbCellera’s employees began working round-the-clock over a weekend in their Vancouver offices, ultimately finding 550 unique antibodies using their tiny device.

Hansen contacted the pharmaceutical company Eli Lilly and came to an agreement, announced March 13, whereby Lilly would manufacture the best antibody and take it into clinical trials.

But first they had to decide which antibody was the winner.

Daniel Skovronsky, Lilly’s chief scientific officer, said the pharmaceutical company threw the normal years-long process out the window and immediately began scaling up to make the top 100 antibodies to save time, even though only one would proceed.

The company worked with AbCellera, the National Institute of Allergy and Infectious Diseases, and academic researchers to conduct experiments on the antibody candidates. By late April, they had to pick which, if any, should proceed to the last and most expensive stage of scale-up.

The best candidate, they determined, was antibody No. 555.

“This was a tough decision,” Skovronsky said. “There were mixed views.”

The first patient was dosed on May 29, 91 days after AbCellera received the blood sample. It became the world’s first study of a potential covid-19 antibody treatment in humans, according to Lilly. The national registry of clinical trials indicates that Phase 2 is expected to be completed in August.

At Vanderbilt, Crowe wanted a better sample than the initial one obtained in February. By mid-March, his team found two people in the United States who had been infected 50 days earlier in China.

After screening the samples, his team narrowed their list to the 30 best antibodies and then interacted with companies interested in producing them.

IDBiologics Inc., a Nashville-based biotechnology start-up that Crowe co-founded, will begin human trials with one of the antibodies in August, he said, with possible availability in the United States under emergency use early next year if all goes well.

After licensing six antibodies from Vanderbilt and screening their own in house, AstraZeneca picked two antibodies to take into clinical trials this summer as a pair, said Mene Pangalos, executive vice president for biopharmaceutical research and development.

The global pharmaceutical industry can produce billions of vaccine doses, but it lacks the capacity to manufacture antibodies at such a large scale. At least initially, the antibodies won’t be delivered using RNA, although Duke University plans to manufacture an RNA version of its antibody, meeting the original DARPA vision for the program.

Wattendorf, who has left DARPA and now works at the Bill and Melinda Gates Foundation, said that looking back 10 years, the agency was trying to solve the problem of speed to protect American forces.

“These things were funded to be fast,” Wattendorf said. “They were not actually funded to be global scale.”

Other DARPA efforts did take aim at the scale question. The agency, for example, funded technology to produce vaccines using plants instead of chicken eggs — an approach that has the benefit of easy mass scale-up. One of the firms DARPA funded, Quebec City-based Medicago, began Phase 1 clinical trials in mid July with a covid-19 vaccine produced in a tobacco-like plant and plans to enter Phase 2 and 3 trials in October.

Mass production and its costs are now a problem that governments the world over are looking to solve, all while watching the results of the fastest-moving clinical trials.

“While we’re all hoping our therapies work, at the end of the day, we all hope somebody’s therapy works,” Pangalos said. “Because we all want to get back to some semblance of reality.”

Officials clarify military role in coronavirus vaccination amid wariness
https://rollcall.com/2020/11/05/officials-clarify-military-role-in-coronavirus-vaccination-amid-wariness/

Officials’ recent comments reflect growing concerns that conflicting messages and deep distrust could jeopardize a vaccine’s success
U.S. Army General Gustave Perna says the U.S. military is helping Operation Warp Speed with things like planning, logistics, augmentation and program support. (Chip Somodevilla/AFP via Getty Images file photo/Pool)

By Emily Kopp
Posted November 5, 2020 at 6:30am
President Donald Trump has often touted the role of the military in distributing a COVID-19 vaccine, but health officials close to the process who are concerned about public distrust are taking pains to say the federal government won’t actually be handling vaccines.

The president said at the final presidential debate that the distribution of a vaccine would be swift because he’s “counting on the military.”

“We have our generals lined up, one in particular that’s the head of logistics. … He’s ready to go,” Trump said Oct. 22.

But Paul Mango, a spokesman for Operation Warp Speed, the federal effort to develop vaccines, clarified the next day: “It is extremely unlikely that anyone from the government will touch a vaccine, whether that’s loading a truck, unloading a truck, moving dry ice or actually injecting the vaccine prior to Americans getting it.”

Mango said the Defense Department would oversee logistics from a distance. Operation Warp Speed is led by the departments of Defense and Health and Human Services.

“I know what the president means because [Operation Warp Speed leader Gen. Gustave Perna] has briefed him several times on this, and that is we have the best logisticians in the United States at the Department of Defense,” he said. “Every logistical detail you could think of: needles, syringes, swabs, bandages, dry ice, trucks, U.S. marshals guiding those trucks, planes, flying in equipment, getting vaccines out.”

Perna clarified at an Oct. 27 event that the military is helping with things like planning, logistics, augmentation and program support.

“There will not be this vision that some people have that there’ll be Army trucks driving through the streets delivering vaccine,” he said, adding that is not “feasible or the right way to do it.”

Public confusion
Even if federal troops do not end up handling vaccines, National Guard units operating under control of a governor may do so in many states, which could lead to public confusion.

A review by CQ Roll Call of 16 states’ COVID-19 vaccination plans indicates that at least nine expect to incorporate state National Guard units under governors’ control. The draft proposals indicate plans for those units to provide backup transportation and security. At least one state, Maryland, signaled intentions to use its National Guard Medical Service Corps to administer shots.

Sandra Quinn, a University of Maryland health equity professor who studies racial differences in flu vaccination rates, said the public is unlikely to make a clear distinction between state-deployed National Guard and Trump’s invocation of “the military.”

Two Democrats on the Senate Armed Services Committee have called for a hearing on the military’s role in Operation Warp Speed. Elizabeth Warren of Massachusetts and Mazie K. Hirono of Hawaii wrote that the organizational structure of Operation Warp Speed, dominated by members of the military, is a “stark departure” from prior public health crises.

A Defense Department spokesperson told CQ Roll Call there is sufficient U.S. commercial transportation capacity so “there should be no need for a large commitment of DOD units or personnel” in distribution. Any DOD support in distribution beyond planning would be an exception, such as if military air assets were needed to deliver vaccines to a remote location, according to the agency.

Federal officials’ careful comments in recent days on the military’s role reflect growing concerns that even with a safe and effective vaccine, conflicting messages and deep distrust could jeopardize its success.

...

https://www.hhs.gov/sites/default/files/pfizer-inc-covid-19-vaccine-contract.pdf

BARDA
https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx

Coronavirus
https://www.jpeocbrnd.osd.mil/Coronavirus/

JPEO-CBRND
Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense

https://www.jpeocbrnd.osd.mil/Portals/90/JPEO-CBRND%20Covid-19%20Placemat.pdf

COVID-19 Fact Sheets
JPL CBRND Enabling Biotechnologies COVID-19 Surveillance Stick
JPL CBRN IM/IT Global Biosurveillance Portal(GBSP)
JPL CBRND Enabling Technologies DNA Vaccine
JPL CBRN Special Operations Forces Biomeme COVID-19 Test Systems
JPM CBRN Protection COVID-19 Negatively Pressurized CONEX (NPC), NPC-Lite (NPCL) JUON
JPM CBRN Medical's Development of Remdesivir: A Broad-Spectrum Antiviral Drug
JPM CBRN Medical COVID-19 Diagnostic Capability: Cepheid GenExpert
JPM CBRN Medical COVID-19 Diagnostic Capability: NGDS 1 (BioFire FilmArray)
Medical Countermeasures Advanced Development and Manufacturing (ADM)

https://www.iambrookjackson.com/_files/ugd/9df0bc_794f8fbb3e1f49e6a2030ab09da77c16.pdf

ARGUMENT
The Statement supports Relator’s assertions that payment was contingent upon the vaccine
receiving emergency use authorization (“EUA”) and that the FDA in making that decision was reliant
upon the accuracy of the data produced in the clinical trials. If, as Relator witnessed and alleges, the
clinical trial protocol was egregiously broken, then the very basis upon which the EUA was granted
would be irrelevant. The government initially recognized the merits of Relator’s claims. The government
made several requests to extend its deadline to either intervene or allow Relator to continue
independently, ultimately deliberating for nearly a year prior to the unsealing of this action. Had the
government truly believed at the time, as they now try to claim, that Relator’s complaint was devoid of
evidence, they would never have required such ample time to investigate. Clearly, the government had an
interest in her allegations upon the initial filing of this action.
While the United States styles its Statement of Interest as supportive of Respondents’ motions to
dismiss, the United States agrees that a FCA claim for fraud in the inducement can be maintained if the
allegations create an inference that clinical trial violations could have “altered FDA’s approval or
authorization decision.” Id., at PageID 2056. The United States claims the inference must be that the
violations at the Ventavia site “actually” altered the FDA’s decision, but the FCA pleading standard is
not one of actuality but of materiality. Id.; See 31 U.S.C. § 3729(a)(1)(B) (imposing liability under the
FCA on any person who “knowingly makes, uses, or causes to be made or used, a false record or
statement material to a false or fraudulent claim”). Whether a false statement is material depends on
whether the false statement has a “natural tendency to influence, or is capable of influencing, the decision
of the decision making body to which it was addressed.” Neder v. United States, 527 U.S. 1, 16, 119

Indeed, the statute expressly defines “material” as “having a natural
tendency to influence, or be capable of influencing, the payment or receipt of money or property.” 3

As recognized in U.S. ex rel. Longhi v. U.S., 575 F.3d 458 (5th Cir. 2009): “All that
is required under the test for materiality, therefore, is that the false or fraudulent statements have the
potential to influence the government’s decisions.” Id., at 470.
In the context of presumptions within the vaccine manufacturer immunity statute, 42 U.S. Code §
300aa–22(b)(2), the Southern District of Texas has held: “The Court cannot accept the fact that the FDA
licensed the vaccines as prima facie evidence that Defendants complied with all regulations […].”
Blackmon v. Am. Home Products Corp., 328 F. Supp. 2d 659, 666 (S.D. Tex. 2004). Similarly, the United
States cannot properly assert that the FDA’s approval, or its continued confidence in Respondents,
operates as evidence that Respondents complied with applicable regulations.
Clinical trial fraud influences the FDA’s decision to grant an EUA as this authorization is always
based on the “totality of the scientific evidence available.” See Doc. 70, PageID 2057-58. The United
States posits ipse dixit that given Ventavia’s clinical trials were “only about 3 percent, or approximately
1,500 of the nearly 44,000 total clinical trial participants” and that was not enough to alter the FDA’s
decision to grant EUA. Id. This analysis, however, does not track the materiality inquiry given proper
inquiry is whether the fraud has the “potential to influence the government’s decision.” See Longhi,
supra, 575 F. 3d at 470. If, as the United States suggests, clinical trial violations may form the basis for a
claim of fraudulent inducement under the FCA, then the only relevant pleading question is whether the
clinical trial violations could potentially influence the FDA’s decision to grant EUA. See Doc. 70,
PageID 2054 (recognizing that “it may be possible to articulate a viable FCA claim based on materially
false or fraudulent statements made to FDA related to a drug or vaccine authorization or approval.”).

..

Even if the EUA was a forgone conclusion - as suggested by the United States, regardless of fraud
at any level given the FDA’s blind faith in Respondents, the relevant inquiry remains whether the clinical
trial violations as pled by Relator could potentially influence the decision making of an objective and
unbiased FDA. Given that the EUA analysis focuses on the “totality of the scientific evidence available,”
and since Relator has pled that “approximately 1,500 of the nearly 44,000 total clinical trial participants”
produced fraudulent data, Relator has sufficiently pled materiality. As a matter of law, a known
threshold of 3% fraudulent data could have “potentially” influenced the FDA’s decision to grant EUA.
And, to the extent it is even necessary, Relator can add to this 3% fraud threshold given that she has since
obtained data from other contracted research companies demonstrating similarly flawed clinical trial data.
Such blatant fraudulent activity at one testing site should also reasonably raise suspicion over the
accuracy of data produced at other sites. Further, the protocol established an end-point number of 164.
Am. Comp., Ex. 6, Doc. 17-1, PageID # 1029. The date for data cut-off for the final efficacy analysis was
November 14, 2020, when a total of 170 confirmed COVID-19 cases were accrued.1 A 3% reduction in
the final population studied for efficacy draws the final number of participants dangerously close to the
minimum established end-point number. Thus, 3% is significant.
Clinical trial fraud is not only a sound basis for a FCA claim, it is also the basis for criminal
charges.2

..

In the Amended Complaint, Relator detailed specific problems with the clinical trials including
the unblinding of participants, all deviations from which would have significant potential to affect both
the risks and benefits reported to the FDA; failure to obtain informed consent; failure to report participant
deaths; and trial data that was fabricated, altered, and hidden from the FDA, easily satisfying plausibility
under the FCA pleading standard. Relator witnesses numerous other clinical trial protocol violations:

1. Relator pled Ventavia failed to report “temperature excursions,” which impacted benefit and risk
by reducing potency and/or reducing potentially reactive agents in the injection.

2. Relator pled that doses of the frozen vaccine concentrate were required to thaw for thirty minutes
before administration, but Ventavia employees were told to hold the frozen concentrate in their
hand to speed up the thawing. This has the potential to change the chemistry and effects.

3. Relator pled clinical trial participants were given their second injection outside of the protocolmandated nineteen to twenty-three day window. On at least four occasions the vaccine
concentrate was over-diluted, which directly affects potency and reduces potential side-effects.

4. Relator pled Ventavia failed to report Serious Adverse Events (“SAEs”) to Pfizer and Icon,
though that information was available via the clinical trial participants’ “electronic diary” entries.
This is perhaps the most egregious violation not only of clinical trial protocol but of public trust.

5. Relator pled Ventavia’s documentation practices were careless, sloppy, inaccurate, and many
times falsified. Pfizer had access to this data and equally failed its oversight responsibilities which
rightfully draws the presumption that data from other clinical trials is just as bad if not worse.

Each act of fraud directly impacted the risk-benefit calculation, which is a key inquiry in granting EUA.
Bypassing protocol taints results, period. Respondents’ failures have a clear and direct impact on the
most important aspects of the FDA’s decision to grant EUA.

https://www.iambrookjackson.com/_files/ugd/9df0bc_794f8fbb3e1f49e6a2030ab09da77c16.pdf

Defendant Pfizer Inc. (“Pfizer” or the “Company”) moved to dismiss this action on April
22, 2022. (ECF 37.) Pfizer’s arguments for dismissal are strong, and the United States—the
named plaintiff in this action—has filed a Statement of Interest agreeing that dismissal is
appropriate. (ECF 70.) Pfizer recognizes that the Court has a heavy workload. The Company
files this brief, respectfully, to bring Pfizer’s pending motion to the Court’s attention and reiterate
Pfizer’s previous request for oral argument.

...

On October 4, 2022, the U.S. Department of Justice (“DOJ”) took the extraordinary step
of filing a Statement of Interest Supporting Dismissal of the Amended Complaint. (ECF 70.) It
is not unprecedented for the Government to file statements of interest supporting plaintiffs in
declined qui tam actions. But the Statement of Interest here is entirely different. It sides with the
defendant, Pfizer, and the other defendants, and urges the Court to dismiss Relator’s lawsuit
because it fails to identify any “false or misleading” claims, its allegations are “implausible,” and
the United States continues to have “full confidence” in Pfizer’s COVID-19 vaccine. (ECF 70 at
6, 11–12.) In short, the Government has concluded there was no fraud here and agrees with Pfizer
that the Court should dismiss this case. To the best of Pfizer’s knowledge, the Government’s
submission is one-of-a-kind; never before has the United States filed a statement of interest seeking
outright dismissal of a relator’s FCA claims.

This unusual development seems to provide a compelling reason for an oral hearing on
Pfizer’s motion to dismiss. That motion was fully briefed as of October 27, 2022. (ECF 75.) To
promote efficiency and judicial economy, the Court has twice refused to start discovery pending
resolution of dispositive motions. (ECF 58, 86.) Under the current scheduling order, discovery is
set to commence on March 15, 2023, one month from today. (ECF 86.) Pfizer would be willing
to present oral argument on or before this date, should the Court deem it helpful.

https://www.iambrookjackson.com/_files/ugd/9df0bc_7c4ba252339448a2a50d3ba75393bc69.pdf

...

Pfizer, in partnership with BioNTech, developed a COVID-19 vaccine using mRNA
vaccine technology.7
In July 2020, the U.S. Army Contracting Command selected Pfizer as the
awardee of a Project Agreement under which Pfizer would deliver 100 million doses of an FDA
authorized or approved vaccine to the Government on a firm fixed price per dose basis, in
accordance with a Statement of Work (SOW).
8
The introductory section of the SOW for the
Project Agreement explains that the “intent” of the project is “to demonstrate that Pfizer has the
business and logistics capability to manufacture 100M doses of its currently unapproved mRNAbased COVID-19 vaccine for the Government.”9
For “background and context,” the SOW
explains that “Pfizer will meet the necessary FDA requirements for conducting ongoing and
planned clinical trials, and with its collaboration partner, BioNTech, will seek FDA approval or
authorization for the vaccine, assuming the clinical data supports such application for approval or
authorization.”10 The SOW expressly recognizes that the vaccine “clinical trials are regulated by
the FDA and HHS,” and specifies that “there is no need for separate regulation by the U.S. Army
Medical Research and Materiel Command.”11

While clinical activities are described in the background section, the scope section of the
SOW states that clinical activities not related to the manufacturing of the vaccine are “out-of
scope” for the project as Pfizer and BioNTech have funded, and will continue to fund, those
clinical activities “without the use of Government funding.”12

..

https://www.iambrookjackson.com/_files/ugd/9df0bc_b7e94cf398e74b35a9182f27e685348b.pdf

UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
BEAUMONT DIVISION
UNITED STATES OF AMERICA
ex rel. BROOK JACKSON,
Plaintiff,
- v -
VENTAVIA RESEARCH GROUP, LLC;
PFIZER INC.; ICON PLC,
Defendants.
CASE NO. 1:21-CV-00008-MJT
ORAL ARGUMENT REQUESTED

PFIZER’S MOTION TO DISMISS RELATOR’S AMENDED COMPLAINT
AND MEMORANDUM OF LAW IN SUPPORT

Defendant Pfizer Inc. (“Pfizer”) respectfully moves, pursuant to Federal Rule of Civil
Procedure 12(b)(6), to dismiss Counts I and II of the operative complaint in the above captioned
matter, which Plaintiff-Relator Brook Jackson (“Relator”) filed on behalf of the United States
under 31 U.S.C. § 3730(b), the qui tam provision of the False Claims Act (“FCA”). The Court
should dismiss the complaint as to Pfizer because: (1) the complaint does not plead a false or
fraudulent claim; (2) its allegations were not material to the Government; and (3) Relator may not
pursue the claims against Pfizer without the Government first pursuing them in an administrative
proceeding.

...

In July 2020, while Pfizer’s vaccine was still under development, DoD entered into an
agreement with the company, as part of Operation Warp Speed, to purchase the first 100 million
doses of the vaccine if FDA later authorized or approved it. (Am. Comp. ¶ 133.) This was before
Pfizer and BioNTech commenced their placebo-controlled efficacy trial, now known as the
“landmark study.” (Id. at ¶ 133.) Because of pandemic-related exigencies, the agreement was not
a standard federal procurement contract, but rather a “prototype” agreement executed pursuant to
4
U.S. Dept. of Defense, Immediate Release: Trump Administration Announces Framework and
Leadership for ‘Operation Warp Speed,’ May 15, 2020, https://tinyurl.com/3yajcvnd.
5
U.S. Dept. of Health & Human Servs., Food & Drug Admin., Development and Licensure of
Vaccines to Prevent COVID-19: Guidance for Industry, June 2020,
https://www.fda.gov/media/139638/download.
6
U.S. Dept. of Health & Human Servs., Food & Drug Admin., Emergency Use Authorization for
Vaccines Explained, Nov. 20, 2020, https://tinyurl.com/46esw485 (“Under an EUA, FDA may
allow the use of unapproved medical products, or unapproved uses of approved medical products
in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions
when certain statutory criteria have been met, including that there are no adequate, approved, and
available alternatives.”).
Case 1:21-cv-00008-MJT Document 37 Filed 04/22/22 Page 11 of 37 PageID #: 1391
7
10 U.S.C. § 2371b, which as of January 1, 2022 is now cited as 10 U.S.C. § 4022. (Am. Compl.,
Ex. 10 at 1079.) Such agreements are executed under DoD’s Other Transaction Authority
(“OTA”) and, as a statutory matter, are not subject to the Federal Acquisition Regulation (“FAR”),
which is the primary regulation otherwise used by Government agencies in their acquisition of
supplies and services with appropriated funds. See 10 U.S.C. § 4022(f)(2); see also NSTI, LLC v.
Defense Energy Ctr. of Excellence, No. 19-03854, 2020 WL 1321530, at *1 (S.D. Tex. Mar. 17,
2020) (“Other Transactions are legally binding contracts that are generally exempt from federal
procurement laws and regulations[.]”). Relator’s allegation that FAR applied to Pfizer’s OTA
agreement, (see, e.g., Am. Compl. ¶¶ 140-143), is simply wrong.7
The key terms of the OTA agreement—the “Contract at Issue” forming the basis for
Relator’s complaint (Am. Compl. ¶ 133)—are found in two instruments: (1) a Base Agreement
executed on July 20, 2020; and (2) a Statement of Work (“SOW”) executed on July 21, 2020.
7
U.S. Dept. of the Air Force, Other Transaction Authority (OTA) Overview,
https://www.transform.af.mil/Projects/Other-Transaction-Authority/ (“Other Transactions
(‘OTs’) are legally binding instruments that may be used to engage industry and academia for a
broad range of research and prototype projects and include the option to extend to production. OTs
are typically defined by what they are not: they are not standard procurement contracts, grants, or
cooperative agreements. As such, they are generally not subject to the federal laws and regulations
that apply to government procurement contracts [such as] FAR[.]”).
Case 1:21-cv-00008-MJT Document 37 Filed 04/22/22 Page 12 of 37 PageID #: 1392
8
Relator attached the SOW to her complaint as Exhibit 10, and this Memorandum attaches the Base
Agreement as Exhibit A.8


The SOW provides that DoD would pay $1.95 billion—or $19.50 per dose—for Pfizer’s
vaccine, contingent on the company first securing FDA approval or an EUA for the product. (Am.
Compl. ¶ 135.) The SOW describes a “large scale vaccine manufacturing demonstration” that
imposes no requirements relating to Good Clinical Practices (“GCP”) or related FDA regulations.
(Am. Compl., Ex. 10 at 1080.) It states explicitly that Pfizer’s “clinical trials” are “out-of-scope,”
“not related” to the agreement, and that the relevant studies were undertaken at Pfizer’s expense
“without the use of Government funding.” (Am. Compl., Ex. 10 at 1087.) Again, Relator’s
allegation that the SOW somehow tied payment to Pfizer’s compliance with every particular of
the clinical protocol or related FDA regulations, (see, e.g., Am. Compl. ¶¶ 275, 278), is mistaken
and refuted by the SOW itself

...

Relator also fails to acknowledge that the SOW, which is attached as an exhibit to her
complaint, states explicitly that Pfizer’s clinical development activities for the vaccine were “outof-scope” and not funded by the Government under the OTA. (Am. Compl., Ex. 10 at 1087.) The
parties included this language because Pfizer, not the Government, was the entity footing the bill
for the very significant costs of the landmark study. For this reason, neither the “Pfizer-DoD
contract” referenced in the complaint, nor the invoices submitted under that agreement, make any
mention of the FDA clinical trial regulations that Relator identifies as supposedly “material to the
[G]overment’s decision to pay the claims.” (Am. Comp. ¶ 281.) Instead, the agreement is crystal clear that the Government could only withhold payment for delivered doses if FDA actually
withdrew authorization or approval of Pfizer’s vaccine. (Am. Compl., Ex. 10 at 1095.)

...

At all relevant times, Pfizer’s vaccine has been authorized, approved, and thus eligible for
payment by the Government. The United States has continued to purchase the product with full
knowledge of the information and allegations arising from Relator’s eighteen days at Ventavia.21
And the Government continues to make the vaccine “free to everyone age 5 and older living in the
United States, regardless of immigration or insurance status.”22 The Government has not wavered
19 Courts routinely take judicial notice of uncontested facts published on a party’s own website,
and it is appropriate for this Court to do so here. See, e.g., O’Toole v. Northrup Grumman Corp.,
499 F.3d 1218, 1224-25 (10th Cir. 2007) (holding district court abused discretion by failing to take
judicial notice of information posted on defendant’s website); Granlund v. Burbank Hill Cmty.
Ass’n., No. 19-01439, 2020 WL 5498075, at *4 (C.D. Cal. Aug. 5, 2020) (“Courts have found it
proper to take judicial notice of a party’s own website pursuant to Fed. R. Evid. 201.”); Raymond
v. Blair, No. 09-5507, 2010 WL 11537936, at *4 n.2 (E.D. La. Oct. 8, 2010) (“The court may take
judicial notice of the information provided on a party’s website.”).
20 It is appropriate for the Court to take judicial notice of this document, which Relator published
on her own website, as well. See supra note 19.
21 U.S. Dept. of Health & Human Servs., Biden Administration Purchases Additional Doses of
COVID-19 Vaccines from Pfizer and Moderna, Feb. 11, 2021, https://tinyurl.com/36m5fyz3;
Pfizer Press Release, Pfizer and BioNTech to Provide U.S. Government an Additional 50 Million
Pediatric Doses of COVID-19 Vaccine to Support Further Preparedness for Future Needs, Oct. 28,
2021, https://tinyurl.com/3zntrv5w.
22 U.S. Dept. of Health & Human Servs., COVID-19 Vaccines, https://tinyurl.com/yyjuu8xt.
Case 1:21-cv-00008-MJT Document 37 Filed 04/22/22 Page 21 of 37 PageID #: 1401
17
from the FDA’s statement that it continues to have “full confidence in the data” underlying its
authoritative approval of Pfizer’s vaccine.23

...

There is nothing on the other side of the scale. The “noncompliance” that Relator alleges—
failure to abide by the clinical trial protocol, FDA regulations, and FAR provisions—are not
“labeled conditions of payment” under the OTA agreement between Pfizer and the United States.
See Escobar, 579 U.S. at 191. Nor does the alleged noncompliance go to the “very essence of the
bargain” between the parties, which entered into a “large-scale manufacturing demonstration” and
agreed explicitly that Pfizer’s clinical development activities would be “out-of-scope.” See id. at
194 n.5. After all it was Pfizer, not the Government, that funded the landmark study. In addition,
Relator “has made no allegations that . . . the continued approval [of Pfizer’s vaccine] persisted
for reasons other than non-materiality.” See Porter, 810 Fed. App’x at 242 n.7.


...

False records and statements must also be “material” to the Government before they can
give rise to an FCA violation. 31 U.S.C. § 3729(a)(1)(B). Here, again, the complaint falters
because the United States has been aware of Relator’s allegations for well over a year, and yet
FDA continues to authorize and approve Pfizer’s vaccine, DoD continues to pay for it, and DOJ
declined to intervene in Relator’s lawsuit. The “lack of any further action” by the Government
“shows that the FDA viewed the information, including that furnished by Relator[], differently
than Relator[] do[es].” See Nargol, 865 F.3d at 35 (affirming dismissal of qui tam claims for lack
of materiality). And, as discussed previously, her complaint proffers no explanation for the
“continued approval” of Pfizer’s vaccine “other than non-materiality.” See Porter, 810 Fed. App’x
at 242 n.7. As a result, the Court should dismiss both of Relator’s causes of action against Pfizer.

...


CONCLUSION
For all of these reasons, Pfizer respectfully asks the Court to dismiss Counts I and II of
Relator’s complaint under Rule 12(b)(6), with prejudice. Pfizer also requests oral argument on
this motion.

Respectfully submitted,
Dated: April 22, 2022 By: /s/ Carlton E. Wessel
Carlton E. Wessel (pro hac vice)
DLA PIPER LLP (US)
500 Eighth Street, NW
Washington, D.C. 20004
Telephone: 202.799.4000
Facsimile: 202.799.5000
Carlton.Wessel@us.dlapiper.com
Andrew J. Hoffman II (pro hac vice)
DLA PIPER LLP (US)
2000 Avenue of the Stars
Suite 400, North Tower
Los Angeles, CA 90067
Telephone: 310.595.3000
Facsimile: 310.595.3300
Andrew.Hoffman@us.dlapiper.com
Meagan D. Self
Texas Bar No. 24078453
DLA PIPER LLP (US)
1900 North Pearl Street
Suite 2200
Dallas, TX 75201
Telephone: 214.743.4500
Facsimile: 214.743.4545
Meagan.Self@us.dlapiper.com
Tommy L. Yeates
Texas Bar No. 22151100
MOORE LANDREY, LLP
905 Orleans Street
Beaumont, TX 77701
Telephone: 409.835.3891
Facsimile: 409.835.2707
tyeates@moorelandrey.com
Attorneys for Defendant Pfizer Inc.

https://rumble.com/v1rs05s-te am-enigma-whistleblower-us-dod-plan-to-exterminate-population-sasha-latyp.html

jeste vic k tomu predchozimu .. nechci tu tahat nejaky komentare k tomu, ale precejen mozna vysvetleni vhodne, co tu vlastne ma jako znamenat

jak to chapu ja - COVID vakciny mely byt armadni projekt (countermeasures) na zabijeni populace, a veskere testovani vakcin bylo proto ze zakona nepovinne(?), a udajne jen jako fasada "Large Scale Vaccine Manufacturing Demonstration" (udajne mel Pfizer zajistit jen fasadu pro verejnost zatimco na vakcinach pry - dle odtajnenych prezentaci - pracovali jini subkontraktori)

Pripad whisteblowerky Brook Jackson ma byt pripadem, kdy Pfizer se hajil tim, ze oni meli jen ukol ten podvod zaridit, takze nemaji pravni odpovednost, a zaloba Brook Jackson mela byt pozastavena... coz pokud se nepletu, soud zamitl, takze ten pripad whisteblowerky se asi projednava dal

Z PDF textu soudnich podkladu je take videt, ze kontraktorem Pfizeru resp. Advanced Technology International byla skutecne armada.

Tedy ty posty posledni tady se tykaji dvou ruznych veci (lidi), aby to nekoho nematlo :-) Ale celkem uzce souvisejicich

https://twitter.com/bmj_latest/status/1504376499939467264


Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial | The BMJ
https://www.bmj.com/content/375/bmj.n2635

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021)
Cite this as: BMJ 2021;375:n2635
Read our latest coverage of the coronavirus pandemic
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Paul D Thacker, investigative journalist
Author affiliations
Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson (video 1), emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Play Video
Video 1
Whistleblower Brook Jackson tells The BMJ about her experience working on the Pfizer covid-19 vaccine trial

Poor laboratory management
On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection
Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.

At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.

Box 1
A history of lax oversight
When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agency’s oversight capacity is severely under-resourced. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. And sometimes oversight occurs too late.

In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. It said, “[I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”5

“There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.

Ventavia and the FDA
A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial.

“People working in clinical research are terrified of FDA audits,” Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. “I don’t know why they’re so afraid of them,” she said. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. “You would think if there’s a specific and credible complaint that they would have to investigate that,” Fisher said.

In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.7

RETURN TO TEXT
The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed “not a good fit,” according to her separation letter.

Jackson told The BMJ it was the first time she had been fired in her 20 year career in research.

Concerns raised
In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:

- Participants placed in a hallway after injection and not being monitored by clinical staff
- Lack of timely follow-up of patients who experienced adverse events
- Protocol deviations not being reported
- Vaccines not being stored at proper temperatures
- Mislabelled laboratory specimens, and
- Targeting of Ventavia staff for reporting these types of problems.


Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.

In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8

In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Other employees’ accounts
In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One of them was one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised, saying that “everything that you complained about was spot on.”

Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Both confirmed broad aspects of Jackson’s complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.

“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”

She added that during her time at Ventavia the company expected a federal audit but that this never came.

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”

A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place.

Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.

Footnotes
Provenance and peer review: commissioned; externally peer reviewed.

Competing interests: PDT has been doubly vaccinated with Pfizer’s vaccine.

This article is made freely available for personal use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

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References
↵Bourla A. An open letter from Pfizer chairman and CEO Albert Bourla. Pfizer. https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla.
↵Ventavia. A leading force in clinical research trials. https://www.ventaviaresearch.com/company.
↵Citizens for Responsible Care and Research Incorporated (CIRCARE). http://www.circare.org/corp.htm.
↵Public Citizen. Letter to Scott Gottlieb and Jerry Menikoff. Jul 2018. https://www.citizen.org/wp-content/uploads/2442.pdf.
↵Food and Drug Administration. Letter to John B Cole MD. MARCS-CMS 611902. May 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jon-b-cole-md-611902-05052021.
↵Department of Health and Human Services Office of Inspector General. The Food and Drug Administration’s oversight of clinical trials. Sep 2007. https://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf.
↵Food and Drug Administration. Bioresearch monitoring. https://www.fda.gov/media/145858/download.
↵FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. Dec 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19.

FDA oversight of clinical trials is “grossly inadequate,” say experts | The BMJ
https://www.bmj.com/content/379/bmj.o2628

BMJ 2022; 379 doi: https://doi.org/10.1136/bmj.o2628 (Published 16 November 2022)
Cite this as: BMJ 2022;379:o2628
Maryanne Demasi, investigative journalist
Author affiliations
maryannedemasi@hotmail.com
Covid-19 vaccines and drugs were developed at “warp speed” and now experts are concerned that the US Food and Drug Administration inspected too few clinical trial sites. Maryanne Demasi reports

On 25 September 2020, the US Food and Drug Administration (FDA) received a complaint by Brook Jackson who had been working for Ventavia Research Group, a Texas based company hired to run clinical trials for Pfizer’s covid-19 mRNA vaccine. Jackson, a regional director, had witnessed problems at three trial sites she was overseeing and complained to an FDA inspector about a range of problems including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events. “I thought that the FDA was going to swoop in and take care of everything. What I was reporting was so important,” Jackson told The BMJ. The FDA did not, however, inspect the trial sites in question.

This lack of oversight was not an isolated case, The BMJ has learnt. Regulatory documents show that only nine out of 153 Pfizer trial sites1 were subject to FDA inspection before licensing the mRNA vaccine. Similarly, only 10 out of 99 Moderna trial sites2 and five of 73 remdesivir trial sites3 were inspected.

Now, facing a backlog of site inspections, experts have criticised the FDA’s oversight of clinical trials, describing it as “grossly inadequate.” They say the problem, which predated covid-19, is not limited to a lack of inspections but also includes failing to notify the public or scientific journals when violations are identified—effectively keeping scientific misconduct from the medical establishment.

The FDA is “endangering public health” by not being candid about violations that are uncovered during clinical trial site inspections, says David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer between 2007 and 2011 and was then appointed as a senior adviser to the FDA commissioner in 2019-21.

“The lack of full transparency and data sharing does not allow physicians and other medical scientists to confirm the data independently and make comprehensive risk-benefit assessments,” continues Gortler, who is now a fellow at the Ethics and Public Policy Center thinktank in Washington DC.

Paused during the pandemic
Between March and July 2020, at the peak of pandemic restrictions, the FDA paused its site inspections and only “mission critical” inspections were carried out. Gortler says, however, that this was the time that the FDA should have ramped up its oversight, not scaled back, especially since covid-19 products were being developed at warp speed and intended for millions of people. “The drug companies took appropriate measures to keep staff safe, which is exactly what the FDA could and should have done,” said Gortler.

A former staffer in the FDA’s Office of Criminal Investigations was also concerned about the agency’s failure to fully tackle Jackson’s complaint about falsified data in Pfizer’s mRNA vaccine trial. In an email dated March 2021, they wrote, “Having worked at the FDA, I see it as surprising, for many reasons, that the agency turned a blind eye . . . They likely feared the criticism they undoubtedly would have received for holding up a vaccine (which they knew they would eventually approve anyway) at the expense of untold lives lost.”

The former FDA employee, who signed a non-disclosure agreement and did not respond to interview requests, went on to write, “My point here is that instead of the regulators protecting the public, they were complicit. At the time, they may have been doing what they believed to be the right thing under extraordinary circumstances. But now, they may soon have some explaining to do.”

The FDA told The BMJ it takes oversight of clinical trials seriously and had adapted to travel restrictions, publishing draft guidance4 for remote regulatory assessments. This guidance describes virtual inspections using live streaming and video conferencing and requests to view records remotely.

Gortler, who is a credentialed FDA inspector, laughed at the proposition. “You can’t do a remote inspection. That’s like saying I’m going to arrest somebody remotely. You have to be there on site and look at every nuance such as cleanliness, organisation, staff coordination—even their body language. During a pandemic, the FDA could’ve put inspectors in hazmat suits if they wanted to, there’s no excuse for not going onsite.”

Historical failure to oversee
The FDA has a long history of failing adequately to oversee clinical trial sites. A report in 2007 by the Department of Health and Human Services’ Office of the Inspector General found the FDA audited less than 1% of the nation’s clinical trial sites between 2000 and 20055 and was highly critical of the agency because it did not have a database of operational clinical trial sites.6 In response to the report, the FDA said it created a dedicated task force and “developed new regulations and guidance further to improve the conduct of clinical trials and enhance the protection of people participating in clinical trials.” The BMJ asked to interview a member of this task force, but the FDA denied our request.

In 2015, Charles Seife, professor of journalism at New York University, conducted an analysis of published clinical trials between 1998 and 2013 in which an FDA inspection found significant evidence of objectionable practices.7 A total of 57 published clinical trials had significant evidence of one or more problems: 39% had falsification or submission of false information, 25% had problems with adverse events reporting, 74% had protocol violations, 61% had inadequate or inaccurate recordkeeping, and 53% failed to protect the safety of patients or had problems with oversight or informed consent. Furthermore, only 4% of the trials that were found to have significant violations were mentioned in the study’s journal publications.

A 2020 Science investigation analysed the FDA’s enforcement of clinical research regulations between 2008 and 2019 and concluded the agency was often light handed, slow moving, and secretive. It said that the FDA rarely levelled sanctions and when it did formally warn researchers about breaking the law, it often neglected to ensure that the problems were remedied.8

It has been 15 years since the Office of Inspector General report and the FDA still has no record of how many clinical trial sites are operating across the US and abroad. The agency told The BMJ it does not compile an annual list of clinical investigational sites submitted for review because it is “resource intensive.”

“It’s unacceptable,” said Gortler. “All it would take is sending a blanket communication to all sponsors or applicants requesting they provide a list of all their international and domestic clinical trial sites. Also, the FDA should publish the names, inspection dates, and unredacted findings at each of these sites clearly on its website, not buried somewhere, nearly impossible to find.” He believes the agency should have implemented a policy decades ago. “The public has a right to learn immediately about any violations before choosing to use an FDA regulated product,” he says.

Some 65% of the FDA’s funding for the evaluation of drugs comes from industry user fees and in return the agency has mandated deadlines for decisions on new product applications. Some experts argue this has been a major contributor to the FDA being rushed and having insufficient resources for other critical activities.9

Insufficient staff and low morale
Historically, the FDA has faced challenges recruiting and retaining sufficient medical staff to meet its needs. According to a Government Accountability Office report published in January 2022, the turnover rate for FDA staff in key scientific areas was twice that of other government agencies in 2007, leaving the agency unable to fulfil its mission.10 Around 70% of the FDA’s career employees working in 2008 were eligible to retire by the end of 2014. Moreover, in 2018, medical product staff in “mission critical” occupations had salaries that were at least 20% lower than the average private sector salary for the same occupations, contributing to low morale. A news report said the pressures of work during the pandemic had led to two FDA reviewers dying by suicide.11

Despite the estimated hundreds of thousands of clinical trial sites in operation across the US and abroad, the FDA told The BMJ that it only has 89 inspectors for its bioresearch monitoring programme, which assure the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications. The FDA told The BMJ it is recruiting more inspectors to reach its yearly average of 100.

“I don’t think that it is a sufficient number of staff to do that kind of level of oversight,” says Jill Fisher, professor of social medicine at the University of North Carolina. “The FDA must have enough of a presence to dissuade investigative sites from committing fraud,” she continues.

Secrecy of inspection findings
Occasionally, the FDA will uncover objectionable practices, such as failure to obtain informed consent, falsification of data, or violations in adverse event reporting.

The FDA publishes its inspection reports12 but the database is not comprehensive, nor are the reports proactively disclosed. When they are disclosed there can be extensive redactions making it difficult to link problems to a particular drug or clinical trial. “FDA redactions can render the document useless—it’s to the point of being comical,” says Gortler, whose current work focuses on FDA oversight and accountability. “Public health information should not be redacted like that,” he says.

The FDA does not typically notify journals when a site participating in a published clinical trial receives a serious warning, or alert the public about the research misconduct it finds.13

Rafael Dal-Ré, physician epidemiologist at the Health Research Institute-Fundación Jiménez Díaz University Hospital, Madrid, Spain, finds this concerning14 and points to the example of the anticoagulant drug rivaroxaban.

The FDA inspected trial sites of the Record 4 trial and identified serious deficiencies at eight of the study’s 16 trial sites.14 The violations were so numerous and severe that the FDA excluded the trial from its pile of evidence during the drug’s approval. But when the study was published in the Lancet in 200915 there was no mention of the data integrity problems and the paper has been cited more than 1100 times by others.14 When The BMJ sought comment from the authors of the Record 4 study, some said they were not fully aware of the data integrity problems prior to our inquiries. The lead author, Alexander Turpin, said he was seeking more information from the drug company. The Lancet told The BMJ it was looking into the matter.

“If research misconduct is identified, the FDA may reject the affected data from the product’s safety and efficacy evaluations, but then fail to disclose these data in the product labelling,” added Dal-Ré.

Gortler finds it unconscionable that the FDA withholds this information from the public. “Misconduct should be released immediately. It’s malpractice not to; it’s irresponsible,” he says.

In response to the criticism the FDA said that it does not always monitor all publications of data that were submitted to the agency, nor does it have the authority to demand that a journal retract an article.

Road to reform
Fisher says the FDA needs better resourcing. “The clinical trials industry has become a complex global enterprise, and the FDA does not have the resources to oversee all the research that is happening, even within the US. The FDA needs to be better funded and staffed to conduct inspections. At a minimum the agency needs to inspect sites when complaints or concerns have been filed,” she says.

Gortler doesn’t agree, however, that the FDA is under-resourced. With a total budget of $6.1bn in 2021, he suggests the agency needs to be leaner and more efficient, with employees interested in improving public health. “The bottom line is that the FDA has over 18 000 full time employees, more than any other drug regulatory agency by far, so it could have retrained and retooled anybody to tackle the need for increased inspections,” he says. “Half of its budget, about $3bn, is discretionary, which means it could have hired contractors, retirees, or repurpose existing workers. It chose not to. The FDA was just yawning its way through the pandemic. The entire agency is broken.”

“It felt like we were being told to hide things”: FDA’s approval of antibiotic Ketek
In 2004, the FDA approved Sanofi-Aventis’s new antibiotic Ketek (telithromycin) for outpatient treatment of community acquired respiratory tract infections. Since then, it has been implicated in hundreds of reported cases of severe liver injury and dozens of deaths, triggered two Congressional hearings, and led to reforms of the agency’s processes. In 2007, the FDA added a warning to Ketek’s label and removed all indications except for bacterial pneumonia.

David Ross was an FDA medical reviewer who led the initial safety review for Ketek in 2001, as part of a 10 year career at the agency’s Center for Drug Evaluation and Research. In his original review Ross, now an associate clinical professor of medicine at George Washington University School of Medicine and Health Sciences, found that Ketek’s risks included liver injury and other serious adverse events that were concerning given the millions of antibiotic prescriptions written annually for respiratory tract infections.16

In 2001, the FDA recommended to Sanofi-Aventis that the company gather additional safety data. Sanofi-Aventis conducted Study 3014, a 24 000 patient safety study done in only five months. The FDA’s limited resources only allowed one out of 1800 sites to be inspected initially.

The agency decided to inspect the highest enrolling site, reasoning that failure to find any problems there would allow all the other sites to be considered clean. “The FDA inspector found evidence of blatant fraud almost immediately. For example, patients being enrolled at times when the clinic was supposedly closed,” said Ross.

The inspector reported her findings to FDA’s Office of Criminal Investigations, with serious protocol violations subsequently found at several other high enrolling sites. Eventually, the site investigator pleaded guilty to fraud and served a 57 month prison sentence.

At a 2003 public meeting of the FDA’s anti-infective advisory committee, data from Study 3014 were presented to the panel without disclosing the numerous violations and data integrity problems found at the initial trial site, which sparked a criminal investigation. Janice Soreth, Ross’s division supervisor at the time, has previously said that there was no intention to deceive the committee and that the violations were not disclosed so as not to compromise the ongoing criminal investigation.17 But Ross says he was appalled: “I felt like we were being told to hide things from the advisory committee.”

Unaware of the integrity problems, the committee voted 11 to 1 to recommend approval of Ketek. The FDA granted the drug approval on 1 April 2004. In a memorandum from the FDA, the agency said it was “difficult” to rely on Study 3014 for its approval because of the data integrity problems, instead using spontaneous adverse events reports for its understanding of Ketek’s overall risk-benefit profile, which goes against standard drug review practice.18 The first Ketek associated death from liver injury was reported to the FDA seven months later.16

A series of events unfolded during the drug approval process, which would later be revealed at a Congressional hearing in 2007. Ross testified under oath that when he submitted his follow up safety review in 2004, concluding that Ketek carried far too much risk to ever be approved for relatively minor conditions such as bronchitis and sinusitis, Soreth asked him to “soften” the language so that it would give the leadership “more wiggle room.” He told the hearing he sent Soreth a revised version for signing but—without telling her—also put the original in the electronic archive. Soreth did not testify in the hearing and denies this allegation. “No one ordered a change in Dr Ross’s review. He was free to keep his original draft,” she told The BMJ. “His review, moreover, did not include Aventis’s final submission to the agency.”

Ross left the division after Ketek’s approval in 2004 and then left the FDA in 2006, saying “the FDA did nothing for months and they just watched as the adverse event reports piled up. Lives could and would have been saved if the FDA acted sooner than it did to publicise Ketek’s risks and put a boxed warning on the drug.”

Whether it was Ross or Soreth who was right about this, the Ketek controversy led to the FDA Amendments Act of 2007, which stated that a reviewer’s work “shall not be altered by management or the reviewer once final.”

The FDA declined to respond when contacted by The BMJ. A spokesperson for Sanofi said the company complied with all the investigations at the time and that it no longer sells Ketek.

Footnotes
Competing interests: I have read and understood BMJ policy on declaration of interests and have no relevant interests to declare.

This feature has been funded by the BMJ Investigations Unit. For details see bmj.com/investigations

This article is made freely available for personal use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

Coronavirus (covid-19) Hub usage terms
https://bmj.com/coronavirus/usage
References
↵FDA. Summary basis for regulatory action: Comirnaty. 2021. www.fda.gov/media/151733/download.
↵FDA. Summary basis for regulatory action: Spikevax. 2022. www.fda.gov/media/155931/download.
↵FDA Center for Drug Evaluation and Research. Summary review: other relevant regulatory issues. 2020. www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214787Orig1s000SumR.pdf#page=29
↵FDA. Conducting remote regulatory assessments: draft guidance for industry. July 2022. www.fda.gov/media/160173/download.
↵FDA Department of Health and Human Services. The Food and Drug Administration’s oversight of clinical trials. 2007. www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf.
↵Tanne JH. FDA is failing to oversee human clinical trials, report says. BMJ2007;335:691.3. doi:10.1136/bmj.39356.358796.DB pmid:17916839CrossRefPubMedGoogle Scholar
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↵Piller C. Official inaction. 1 October 2020. www.science.org/content/article/fda-s-own-documents-reveal-agency-s-lax-slow-and-secretive-oversight-clinical-research.
↵Demasi M. From FDA to MHRA: are drug regulators for hire?BMJ2022;377:o1538. doi:10.1136/bmj.o1538 pmid:35768073FREE Full TextGoogle Scholar
↵US Government Accountability Office. FDA workforce: agency-wide workforce planning needed to ensure medical product staff meet current and future needs. 2022. www.gao.gov/assets/gao-22-104791.pdf.
↵Eban K. “A tsunami of randoms”: how Trump’s covid chaos drowned the FDA in junk science. Vanity Fair. 19 January 2021. www.vanityfair.com/news/2021/01/how-trumps-covid-chaos-drowned-the-fda-in-junk-science.
↵FDA. Inspection observations. www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations.
↵Doshi P, Godlee F. The wider role of regulatory scientists. BMJ2017;357:j1991. doi:10.1136/bmj.j1991 pmid:28450290FREE Full TextGoogle Scholar
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↵Turpie AGG, Lassen MR, Davidson BL, et al., RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet2009;373:1673-80. doi:10.1016/S0140-6736(09)60734-0 pmid:19411100CrossRefPubMedWeb of ScienceGoogle Scholar
↵Ross DB. The FDA and the case of Ketek. N Engl J Med2007;356:1601-4. doi:10.1056/NEJMp078032 pmid:17442902CrossRefPubMedWeb of ScienceGoogle Scholar
↵Soreth J, Cox E, Kweder S, Jenkins J, Galson S. Ketek--the FDA perspective. N Engl J Med2007;356:1675-6. doi:10.1056/NEJMc076135 pmid:17442912CrossRefPubMedWeb of ScienceGoogle Scholar
↵Graham DJ. Telithromycin and acute liver failure. N Engl J Med2006;355:2260-1. doi:10.1056/NEJMc066372 pmid:17124030CrossRefPubMedWeb of ScienceGoogle Scholar

Vaccine trial misconduct allegation – could it damage trust in science?
https://theconversation.com/vaccine-trial-misconduct-allegation-could-it-damage-trust-in-science-171164

This article has been updated and certain passages, which are the subject of disagreement between parties referred to in the article, have been removed.

The success of medical research has been one of the few positives of the COVID pandemic. The effectiveness of vaccines in preventing deaths (see graph below), is particularly impressive given the short time in which they were developed. But if recent allegations from a whistleblower about a Pfizer vaccine trial can be proven, they would indicate that time and financial pressures may have led to serious misconduct.

The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to the BMJ. She alleges that Ventavia falsified data, “unblinded” patients (that is, researchers could see who was receiving the vaccine and who the placebo), employed inadequately trained vaccinators, and was slow to follow up on adverse events during one of the final trials.

Given the size of the vaccine trial, and the many centres involved, bad data from a few rogue centres is unlikely to fatally undermine the evidence needed for licensing the Pfizer vaccine. But it is important to examine allegations because research misconduct is a serious issue, especially if linked to a vaccine being given to millions of people. If the alleged activity turns out to be true, there must be severe consequences for Ventavia and those involved.

The international rules for conducting clinical trials are described in the World Medical Association’s Declaration of Helsinki. This document lays out the conditions and considerations needed for researchers and doctors to act with integrity when conducting research.

Research integrity has two aspects, both of which are alleged to have been a problem at Ventavia. Poor record-keeping, glossing over errors and drugs stored inappropriately are breaches of methodological integrity, while reports of participants waiting in corridors (when they were supposed to be under observation) and delays in following up side-effects are breaches of ethical integrity.

While ethics and safety regulators play an important role in the design and conduct of trials, ethics committees and inspectors cannot be aware of everything that goes on. Ethical conduct in particular is based on trust that researchers will carry out their work under the rules agreed with the ethics committee. Similarly, safety regulators are not in the position of policing all aspects of trials. In this case, while the US regulator (the Food and Drug Administration) was reportedly trying to monitor the trial, it only inspected nine out of 153 sites, not including any of the Ventavia sites.

A spokesperson for Ventavia provided the following comment:

Ventavia is aware of recent accusations in an article written by Paul Thacker [investigative reporter and author of the BMJ article]. Mr. Thacker did not contact Ventavia prior to publication. These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. The allegations were investigated and determined to be unsubstantiated. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines.

Complicated activity
Medical research is a complicated activity and the careful work needed to produce reliable results often takes a long time. Indeed, recent problems at a UK testing centre – where around 43,000 people may have been wrongly told that their COVID test was negative – show that it is easy to make mistakes, even when conducting the same laboratory process tens of thousands of times. For this reason, universities and other research institutions are required to provide training in research integrity, alongside having processes to detect and investigate serious integrity issues.

In parallel, work by research funders, academic societies and research charities is continuously trying to identify the pressures that lead to integrity issues. Perhaps unsurprisingly, time and money pressures frequently top the list. As the COVID dust starts to settle, more allegations like this will undoubtedly be made.

While misconduct is always regrettable, it is not unexpected. Sometimes the scientific method can be presented in an almost mythical way as if it is somehow entirely objective. This view is incorrect.

In reality, science is a human activity conducted by people with different motivations. But perhaps the difference between science and other activities is that systematic efforts are made to check and confirm results. This does not stop some worrying that science has a “reproducibility crisis” (the problem that not all experiments can be repeated), or that there is a great deal of research waste (research with no societal benefits), or that misconduct requiring retractions does occur, but scientists are aware of these problems and are trying to address them.

Take, for instance, the former physician Andrew Wakefield’s fraudulent research – published in The Lancet, but subsequently retracted – which claimed a link between the MMR vaccine and autism. This was a clear and serious breach of research integrity, and although it caused a lot of harm, it also led to thousands of studies both refuting the fraudulent research, but also arguably advancing vaccine science to the point that it was able to contend with SARS-CoV-2 when it arrived. The Wakefield scandal also caused a great deal of self-reflection and many positive actions trying to prevent such things from ever happening again.

COVID science has produced some amazing results, but it is still too early to fully assess the overall value of the research efforts. Given the vast amount of funding, and thousands if not millions of researchers working on COVID, alongside the successes there will inevitably be more examples of alleged misconduct – leading, inevitably, to sensationalist headlines. But when this happens, it is important to remember how many lives the vaccines and other treatments have saved. Yes, science is a human activity. Yes, integrity can be a problem. Yes, fraud and misconduct will occasionally occur, but science also produces remarkable results.

Video from Stockholm Conference, Lakaruppropet, January 21, 2023
https://www.bitchute.com/video/LerpitTRzKAJ/

Corona Investigative Committee, Session 140
https://www.bitchute.com/video/12cFNsOQvM9H/

I was invited to speak about the DOD involvement in countermeasures, and also comment on the recent Project Veritas undercover video release of "Pfizer manipulating viruses" story.

21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies | U.S. Code | US Law | LII / Legal Information Institute
https://www.law.cornell.edu/uscode/text/21/360bbb-3
(k)Relation to other provisions
If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].

related

Pfizer Asks Court to Dismiss Whistleblower Lawsuit Because Government Was Aware of Fraud
https://www.theepochtimes.com/health/pfizer-asks-court-to-dismiss-whistleblower-lawsuit-because-government-was-aware-of-fraud_4578832.html

The lawyer representing whistleblower Brook Jackson said Pfizer is arguing the court should dismiss Jackson’s lawsuit alleging fraud in Pfizer’s COVID-19 clinical trials because the U.S. government knew about the wrongdoings but continued to do business with the vaccine maker.

A lawsuit filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other acts of fraud during Pfizer’s COVID-19 clinical trials is paused following a motion by the defendants to dismiss the case.

In an interview with The Defender, Jackson’s lawyer said Pfizer argued the lawsuit, which was filed under the False Claims Act, should be dismissed because the U.S. government knew of the wrongdoings in the clinical trials but continued to do business with the vaccine maker.

Under the False Claims Act, whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government.

However, a 2016 U.S. Supreme Court decision that expanded the scope of a legal principle known as “materiality” resulted in a series of federal court decisions in which fraud cases brought under the False Claims Act were dismissed.

As interpreted by the Supreme Court, if the government continued paying a contractor despite the contractor’s fraudulent activity, the fraud was not considered “material” to the contract.


Pfizer is a federal contractor because it signed multiple contracts with the U.S. government to provide COVID-19 vaccines and Paxlovid, a pill used to treat the virus.

“Pfizer claims they can get away with fraud as long as the government would write them a check despite knowing about the fraud,” attorney Robert Barnes said.

The other two defendants in the case are Ventavia Research Group, which conducted vaccine trials on behalf of Pfizer, and ICON PLC, also a Pfizer contractor.

In an attempt to strengthen the False Claims Act’s anti-retaliation provisions and install new safeguards against industry-level blacklisting of whistleblowers seeking employment, Congress in July 2021 introduced the False Claims Amendments Act of 2021.

In December 2021, Pfizer hired a well-connected lobbyist, Hazen Marshall, and the law firm Williams & Jensen to lobby against the bill.

Pfizer previously was heavily fined in connection with the False Claims Act. As part of a 2009 settlement, the company paid $2.3 billion in fines — the largest healthcare fraud settlement in the history of the U.S. Department of Justice — stemming from allegations of illegal marketing of off-label products not approved by the U.S. Food and Drug Administration (FDA).

“Pfizer, one of the most criminally fined drug companies in the world, wants to weaken the laws that hold them accountable,” Barnes told The Defender.

Congress has taken no action on the False Claims Amendments Act since November 2021, when the bill was added to the Senate’s legislative calendar.

Barnes said the outcome of Jackson’s case against Pfizer is significant not just for his client, but also for the American public.

“This case will determine if Big Pharma can rip off the American people using a dangerous drug that harms millions without any legal remedy because they claim the government was in on the scam.”

Jackson was a regional director for Ventavia for a brief period in 2020 but was fired after she notified the FDA about issues with Pfizer’s vaccine trials.

After she was fired, she gave The BMJ a cache of internal company documents, photos and recordings highlighting the alleged wrongdoing by Ventavia.

The documents she provided contained evidence of falsified data, blind trial failures and awareness on the part of at least one Ventavia executive that members of the company’s staff were “falsifying data.”

Jackson’s documents also provided evidence of administrators who had “no training” or medical certifications, or who provided “very little oversight” during the trials.

Jackson filed her complaint in August 2021, in the U.S. District Court, Eastern District of Texas, Beaumont Division, alleging Pfizer, Ventavia and ICON “deliberately withheld crucial information from the United States that calls the safety and efficacy of their vaccine into question.”

A district court judge in February unsealed Jackson’s complaint, which included 400 pages of exhibits.

According to the complaint, Jackson, who had more than 15 years of experience working with clinical trials, “repeatedly informed her superiors of poor laboratory management, patient safety concerns and data integrity issues” during the approximately two weeks she was employed by Ventavia.

“Brook [Jackson] brought a Qui Tam action and a retaliatory discharge case against Pfizer and others for fraud on the people concerning Pfizer’s false certifications to the U.S. Department of Defense about the safety and efficacy of their COVID-19 vaccine,” Barnes said.

A Qui Tam case refers to a provision under the False Claims Act that allows individuals and entities with evidence of fraud against federal programs or contracts to sue the wrongdoer on behalf of the U.S. government

“She was part of the clinical trials, witnessed extraordinary malfeasance, blew the whistle, and was quickly fired after she blew the whistle.”

Barnes said his legal team will in August file its opposition brief to Pfizer’s motion to dismiss, and the judge may rule on the motion to dismiss by fall 2022.

(PDF) US District Court for Eastern Texas - USA ex rel, Brook Jackson v. Ventavia Research Group - recently unsealed qui tam action against vaccine entities: Pfizer Inc., Icon PLC, and Ventavia Resear...
https://www.academia.edu/71772143/US_District_Court_for_Eastern_Texas_USA_ex_rel_Brook_Jackson_v_Ventavia_Research_Group_recently_unsealed_qui_tam_action_against_vaccine_entities_Pfizer_Inc_Icon_PLC_and_Ventavia_Research_Group_LLC

White Noise | Official Trailer | Netflix
https://www.youtube.com/watch?v=SgwKZAMx_gM


The eerie parallels between Netflix's "White Noise" and the Ohio train derailment disaster | Salon.com
https://www.salon.com/2023/02/15/noise-ohio-train-derailment/

read "White Noise" in San Francisco, miles from home. I was living in the golden state for an all-too brief time, so far from rural Ohio where I was raised and where I would return to raise my child. In the sunshine, the beach a mere drive away, it seemed like a fine place to disappear into Don DeLillo's 1985 novel about an Ohio college professor and his large family whose lives are upended by a toxic airborne event. I enjoyed the novel at the time. I don't think I could read it again, not now, not in this world and not knowing what I do about my home's long history of exploitation by industry and ecological disaster, a legacy that is ongoing.

In the book "White Noise," winner of the National Book Award, Jack Gladney, his wife Babette and their many children from various marriages are forced to evacuate after a train derails near their pastoral Ohio home, causing an explosion which morphs into a dangerous, toxic cloud. Sound familiar?

Related

EPA issues rare veto, halting Alaska's Pebble mine
Shortly after Noah Baumbach adapted and directed a film version of "White Noise," now streaming on Netflix, starring his partner Greta Gerwig and Adam Driver, a freight train carrying hazardous chemicals derailed in rural Ohio. The story is still developing, and the environmental impact may not be fully known for years, but the tragedy bears an eerie resemblance to many elements of the film.

"How familiar this all seems to us," Jack (Driver) says in the movie. Salon unpacks the similarities between "White Noise" and the ecological disaster in Ohio.

01
The Ohio setting
Image_placeholderWhite NoiseGreta Gerwig as Babette and Sam Nivola as Heinrich in "White Noise." (Netflix)
"White Noise" is set in Ohio, where Jack teaches at a college aptly known as the College-On-The-Hill. He and his family live in the small, picturesque town of Blacksmith, which is fictionalized. The movie was filmed almost entirely in Ohio, a prep school in Willoughby, Ohio, filling in for the College-On-The-Hill. Other classroom, lab and student center scenes were shot at the University of Akron, Baldwin Wallace University and Kent State University while the family home is a real house in the college town of Oberlin.



In real life, the train derailed in East Palestine, Ohio, a small town near the Pennsylvania border. Some residents of East Palestine worked as movie extras during the filming of "White Noise" in their home state.

02
Train derailment
Image_placeholderWhite NoiseWhite Noise (Netflix)
"White Noise" is spilt into parts. The second part, titled "The Airborne Toxic Event" concerns what happens when a tanker truck carrying toxic, flammable material crashes into a passing train, due to the truck driver's drunk driving. The train derails in the countryside. Cars smash into each other and the tanker is crushed, releasing a viscous substance. A fireball erupts. The rest of the film deals with the aftermath of the crash, in both large and small, personal ways.



In East Palestine, on Feb. 3, a Norfolk Southern train with 20 cars containing hazardous materials derailed and then caught on fire. As Ben Ratner, one of the East Palestine locals who appeared as extras in "White Noise," told CNN, "The first half of the movie is all almost exactly what's going on here."

03
The cloud
Image_placeholderWhite NoiseWhite Noise (Netflix)
"There's lots of smoke, and I don't like the looks of it," Jack's teen son (Sam Nivola) says to him in the film, after the child has been studying the site of the train derailment through binoculars via the family's roof. In the movie, an explosion from the derailment causes a toxic cloud that can be viewed for miles. It looks uncannily like the real scene in East Palestine of the dark, purple-blue cloud witnessed over farmland and pastures (a cloud that emerged after the so-called "controlled release" of the train cars' chemicals). In the fictional film, the cloud later resembles a massive, purple-tinged storm cloud, which wouldn't be out of place in "Ghostbusters."

04
Conflicting emergency messages
Image_placeholderWhite NoiseChloe Fineman as Simuvac Technician in "White Noise." (Wilson Webb/Netflix)
In "White Noise," the family is first told to evacuate. Hours after the incident, believing the derailment and resulting explosion to be far enough away that it doesn't pose a threat, the family sits down to dinner when air raid sirens go off. Then the fire chief hurries through the neighborhood in his car, blasting a message to evacuate all residents. Jack's family flees in their battered station wagon. They don't get far, jammed on the road with all the other escaping families. But then the emergency broadcast on the radio tells them a different message: to stay inside and shelter indoors. No one should be outside, the new messaging says. Or on the roads.



The people in East Palestine — and possibly, in the entire Ohio River Valley area – are dealing with similar mixed messages. Hundreds were forced to evacuate as Norfolk Southern burned carcinogens from the crash. After merely a few days, people were told it was safe to return. But the EPA continues to monitor the air, residents have described burning in their eyes and fish, livestock and pets have all been reported dead or sick.

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05
Uncertain future
Image_placeholderWhite NoiseWhite Noise (Wilson Webb/Netflix)
In the last part of "White Noise," the main characters deal with their fear of death in various ways — though, as a seminal postmodernist story, perhaps "deal" is too strong a word. Little is truly resolved or seems certain.



So too East Palestine, Ohio, and multiple states bordering the Ohio River, may be facing an uncertain future. The derailed and burned cars contained dangerous chemicals including butyl acrylate, ethylhexyl acrylate, isobutylene, and especially concerning: vinyl chloride, which NPR describes as "a carcinogen that becomes a gas at room temperature." It breaks down in the sun, can cause headaches and dizziness, but it has severe long-term risks as well. NPR writes, "People who breathe the chemical over many years may also experience liver damage," and due to its "tiny atoms," residents can't just clean it off.



GoFundMe pages have been set up for East Palestine, with other charities for people and animals impacted by the disaster accepting donations as well.

https://edition.cnn.com/2023/02/15/us/newsnation-reporter-charges-dropped/index.html



The criminal charges filed against the NewsNation reporter who was arrested while reporting at a news conference in East Palestine have been dropped, Ohio Attorney General Dave Yost announced Wednesday.

Evan Lambert-McMichael was arrested after reporting live during a news conference last week held by Ohio Gov. Mike DeWine and other officials who were updating the train derailment in East Palestine, CNN previously reported.

Body camera footage shows officials approaching Lambert-McMichael and asking him to stop his reporting as it was too loud during the press conference. The footage also shows an argument break out and Ohio National Guard’s adjutant general, Maj. Gen. John Harris, approaching and pushing Lambert-McMichael.

Lambert-McMichael was charged with resisting arrest, a second-degree misdemeanor, and criminal trespass, a fourth-degree misdemeanor, according to Yost.

“While journalists could conceivably be subject to criminal charges for trespassing in some situations, this incident is not one of them,” Yost wrote in a statement. “The reporter was lawfully present at a press conference called by the Governor of the state. His conduct was consistent with the purpose of the event and his role as a reporter.”

In a statement on Twitter, Lambert-McMichael spoke about the incident.

“It is by design that reporters aren’t meant to become the story,” he began.

“I’m still processing what was a traumatic event fore me, in the context of a time where we are hyper aware of how frequently some police interactions with people of color can end in much worse circumstances. That is not lost on me,” Lambert-McMichael noted.

“I am doing alright. And I will be OK. I will also continue to do my job without fear or favor in service of the public. I also hope what happened to me shines further attention on the people of East Palestine, who rightly have questions about their safety in light of an environmental hazard,” he added.

DeWine said Wednesday on “CNN This Morning” he has “never had a problem” during any of the news conferences he’s held during his tenure as governor.

“This reporter who was reporting live from the back of the room never should have been asked to stop, never should have been told to be quiet,” the Republican governor told CNN’s Don Lemon and Kaitlan Collins. “That was a big, big mistake. And you know, the person who did that, I’ve explained to them and I’m sure that he’ll never, never do that again.”

https://edition.cnn.com/2023/02/11/health/ohio-train-derailment-white-noise/index.html

“The first half of the movie is all almost exactly what’s going on here,” Ratner said Wednesday, four days into their evacuation.

https://twitter.com/RepTroyNehls/status/1625591924555128832




East Palestine, Ohio, residents can safely go home, officials say : NPR
https://www.npr.org/2023/02/08/1155570564/east-palestine-ohio-train-derailment

EAST PALESTINE, Ohio — Evacuated residents can safely return to the Ohio village where crews burned toxic chemicals after a train derailed five days ago near the Pennsylvania state line, East Palestine Fire Chief Keith Drabick said Wednesday.

Authorities in East Palestine had warned that burning vinyl chloride that was in five of the derailed tanker cars would send hydrogen chloride and the toxic gas phosgene into the air. They said Wednesday subsequent air monitoring hasn't detected dangerous levels inside or outside the mile-radius evacuation zone, which stretched into Pennsylvania. Drabick said air and water samples taken Tuesday from the evacuation area show it's now safe, and the evacuation order is lifted. He thanked state and federal officials and agencies that helped with the emergency response over the past few days.

Ohio crews conduct a 'controlled release' of toxic chemicals from derailed train cars
NATIONAL
Ohio crews conduct a 'controlled release' of toxic chemicals from derailed train cars
James Justice of the U.S. Environmental Protection Agency said around-the-clock air monitoring has shown normal, un-concerning levels. Hundreds of data points from that "show that the air quality in the town is safe," he said.

He reiterated that there was a robust air monitoring system in place and data from that showed nothing at a level that would be cause for health concern. Monitors did detect toxins in the air during the controlled burn at the derailment site, but other samples outside that area did not.

Many nearby residents left shortly after the derailment, and others were ordered out before the controlled release of the chemicals because of concerns about serious health risks from it.

The commander of the Ohio National Guard previously said that members wearing protective gear would take readings inside homes, basements and businesses as officials aimed to ensure the air was safe before lifting the evacuation order.

Some residents have said they were worried about returning even if authorities say it's OK to go home.

The fire from the chemical release is no longer burning, and crews have started removing some of the wreckage.

About 50 cars, including 10 carrying hazardous materials, derailed in a fiery crash Friday night on the edge of East Palestine. Federal investigators say a mechanical issue with a rail car axle caused the derailment.

No injuries have been reported from the derailment or from the controlled release of the chemicals on Monday, but some people have complained about smelling chlorine and smoke in the air and having headaches.

Those just outside the evacuation zone in East Palestine and in neighboring Beaver County, Pennsylvania, had been urged to stay indoors as a precaution. Officials in neighboring counties have said air samples did not show any worrisome levels of contaminates.

At least one lawsuit has been filed over the derailment. An East Palestine business owner and two other residents sued the rail operator in federal court on Tuesday, alleging negligence by Norfolk Southern and exposure to toxic substances as a result. They're seeking to make it a class-action case for residents and businesses in the evacuated area and people who were physically harmed because of spilled chemicals at the site.

Norfolk Southern declined to comment on the lawsuit.