@StateDept Spent Millions on AutoInjectors to Counteract Nerve Agent Exposure, Guess What Happened?

WaPo’s Jon Swaine has an investigative piece on a $120 million State Department contract on a treatment for nerve agent poisoning. According to the report, WaPo has “obtained internal company records, reviewed emails from Emergent staffers and government officials, and interviewed nine people involved in making, selling or buying the Trobigard injectors.”
WARNING! This will get you mad.

“In June 2017, a director of regulatory affairs at the government contractor Emergent BioSolutions told colleagues that she objected to claims the company was making in a brochure for one of its newer products: a drug injector for victims of exposure to nerve agents.

“Functionality testing has not been successful in this device,” Brenda Wolling wrote in comments obtained by The Washington Post. Regarding a claim that the injector was designed to withstand “challenging operational and logistical conditions,” she wrote, “No testing ever conducted.” Even to describe the product as a “treatment of nerve agent poisoning,” Wolling wrote, “implies that we have efficacy data showing it works.”

Three months later, the Trump administration awarded Emergent a $20 million no-bid contract to supply those very injectors to the State Department. The firm later received a second contract, worth up to $100 million, to supply the agency with more of the injectors — sold under the name Trobigard — and related treatments.”

Apparently, the State Department told Emergent that it had obtained a legal opinion from the FDA’s general counsel saying the department could buy Trobigard for use by U.S. diplomats overseas, citing a company record. The report says, the company “has not sought approval from the U.S. Food and Drug Administration — a circumstance that bars the product’s sale in the United States.”

“By September 2017, State Department officials were increasingly alarmed at chemical weapons use by the Syrian regime and the Islamic State and were anxious to boost protections for U.S. diplomats. The agency gave Emergent a one-year contract worth $20.5 million to supply auto-injectors. Under the deal, Emergent delivered 456,845 auto-injectors — enough to provide several for each of 58,000 Foreign Service officers and local employees overseas.

No bid competition was held, on the grounds that there was “unusual and compelling urgency” after Pfizer’s production halt, according to contract records. The injectors were needed to protect officials who “operate in countries with active and/or assumed chemical [redacted] programs,” the records show.
[…]
Emergent’s 2017 deal with the State Department entailed a sharp increase in spending by the department above earlier plans. In August 2015, the department had been preparing to pay Meridian $750,000 per year for five years to replace expiring devices, according to records of an abandoned deal.”

The company-funded study in the Netherlands tested the drugs on guinea pigs exposed to sarin gas. That’s right guinea pigs.

“Six weeks after the State Department signed the deal, Emergent’s first study of Trobigard’s drugs was completed. The company-funded study in the Netherlands tested the drugs on guinea pigs exposed to sarin gas and recorded positive findings. As they published their work in a scientific journal, the study’s authors warned that the results “cannot be directly extrapolated to the human situation.”

Can the embattled OIG still take this on as a special project? Can House Foreign Affairs (HFAC) or House Oversight Committee (HORC) take a look?

“In July, Emergent leaders ordered that Trobigard sales materials be scrapped and that the device be moved to a portion of the company’s website that lists products in development, the company confirmed. They also told staffer to make sure all future sales materials for Trobigard were approved by the company’s medical, legal and regulatory departments.

Emergent put together evidence that all injectors bought by the State Department were safe, former employees said. Government officials ultimately agreed. In September 2019, the State Department authorized the payment of a $10 million contract installment to Emergent.”

You need to read this in full. A State Department “no comment” is not acceptable.

Extracted data below from SAM.gov, the new fedbiz, with links to the contracts. Are there more that we’ve missed?

EMERGENT COUNTERMEASURES INTERNATIONAL LTD

  • Unique Entity ID (DUNS)220984617
  • CAGE CodeU1C03
  • AddressBUILDING 3, LONDON, W4 5YA

Registration

  • Expiration Date Jun 23, 2021
  • Purpose of Registration All Awards
  • Debt Subject to Offset  No

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Report: Covid19-Infected Amcits From #DiamondPrincess Flown Home Against CDC Advice

 

Via WaPo, February 20, 2020:

In Washington, where it was still Sunday afternoon, a fierce debate broke out: The State Department and a top Trump administration health official wanted to forge ahead. The infected passengers had no symptoms and could be segregated on the plane in a plastic-lined enclosure. But officials at the Centers for Disease Control and Prevention disagreed, contending they could still spread the virus. The CDC believed the 14 should not be flown back with uninfected passengers.
[…]
The State Department won the argument. But unhappy CDC officials demanded to be left out of the news release that explained that infected people were being flown back to the United States — a move that would nearly double the number of known coronavirus cases in this country.
[…]

During one call, the CDC’s principal deputy director, Anne Schuchat, argued against taking the infected Americans on the plane, according to two participants. She noted the U.S. government had already told passengers they would not be evacuated with anyone who was infected or who showed symptoms. She was also concerned about infection control.

Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, who was also on the calls, recalled saying her points were valid and should be considered.

But Robert Kadlec, assistant secretary for preparedness and response for the Department of Health and Human Services and a member of the coronavirus task force, pushed back: Officials had already prepared the plane to handle passengers who might develop symptoms on the long flight, he argued. The two Boeing 747s had 18 seats cordoned off with 10-foot-high plastic on all four sides. Infectious disease doctors would also be onboard.

“We felt like we had very experienced hands in evaluating and caring for these patients,” Kadlec said at a news briefing Monday.

The State Department made the call. The 14 people were already in the evacuation pipeline and protocol dictated they be brought home, said William Walters, director of operational medicine for the State Department.

As the State Department drafted its news release, the CDC’s top officials insisted that any mention of the agency be removed.

Read the full report below.
Anyone know if the State Department has a Task Force for Covid-19 already? It looks like U.S. citizens in Hubei Province or those with information about U.S. citizens in Hubei are advised to contact the U.S. Embassy or the State Department at the same email address: CoronaVirusEmergencyUSC@state.gov.
Excerpt from State Dept Special Briefing on Repatriation ofo U.S. Citizens from the Diamond Princess Cruise Ship, February 17, 2020:

OPERATOR: The line of Alex Horton from Washington Post has been opened. Please, go ahead.

QUESTION: Yeah, thanks, everyone, for jumping on this call on a holiday. So I was curious about when discussion with the CDC was executed to make this call. Based on their press release a few days ago, they said there would be screening to prevent symptomatic travelers from departing Japan. The press release you guys issued is very carefully worded when you said, “After consulting HHS, the State Department made the decision to allow those individuals to go on,” those 14.

So is there daylight with CDC and HHS in this decision by you guys to send them forward, and what were some of their objections that you – that you seem to have overturned?

DR WALTERS: This is Dr. Walters. What I’d say is that the chief of mission, right, through the U.S. embassy, is ultimately the head of all executive branch activities. So when we are very careful about taking responsibility for the decision, the State Department is – that is the embassy. The State Department was running the aviation mission, and the decision to put the people into that isolation area initially to provide some time for discussion and for onward, afterwards, is a State Department decision.

There is a – I think where you might see the appearance of a discrepancy is in the definition of symptomatic. Symptomatic – when we use the word “symptomatic,” we’re talking about coughing and sneezing and fever and body aches. Those are symptoms, all right? And as Dr. Kadlec laid out and I reinforced, each one of these 338 [4] people was evaluated by an experienced medical provider, and none of them had symptoms.

Once they were on the bus, we received information about a lab test that had been done two or three days earlier. But it is, in fact – it is a fact that no symptomatic patients – no one with a fever or a cough or lower respiratory tract infection or body aches, or anything that would lead one to believe this person is infected with the virus was – none of that was in place before – at the time a decision was made to evacuate these folks.

 

Amb. Marie Yovanovitch Pens WaPo Op-Ed: These are turbulent times. But we will persist and prevail

 

Marie Yovanovitch: These are turbulent times. But we will persist and prevail.
Feb. 6, 2020 at 3:00 a.m. PST
Via WaPo:

After nearly 34 years working for the State Department, I said goodbye to a career that I loved. It is a strange feeling to transition from decades of communicating in the careful words of a diplomat to a person free to speak exclusively for myself.

What I’d like to share with you is an answer to a question so many have asked me: What do the events of the past year mean for our country’s future?

It was an honor for me to represent the United States abroad because, like many immigrants, I have a keen understanding of what our country represents. In a leap of optimism and faith, my parents made their way from the wreckage of post-World War II Europe to America, knowing in their hearts that this country would give me a better life. They rested their hope, not in the possibility of prosperity, but in a strong democracy: a country with resilient institutions, a government that sought to advance the interests of its people, and a society in which freedom was cherished and dissent protected. These are treasures that must be carefully guarded by all who call themselves Americans.

When civil servants in the current administration saw senior officials taking actions they considered deeply wrong in regard to the nation of Ukraine, they refused to take part. When Congress asked us to testify about those activities, my colleagues and I did not hesitate, even in the face of administration efforts to silence us.

We did this because it is the American way to speak up about wrongdoing. I have seen dictatorships around the world, where blind obedience is the norm and truth-tellers are threatened with punishment or death. We must not allow the United States to become a country where standing up to our government is a dangerous act. It has been shocking to experience the storm of criticism, lies and malicious conspiracies that have preceded and followed my public testimony, but I have no regrets. I did — we did — what our conscience called us to do. We did what the gift of U.S. citizenship requires us to do.

Unfortunately, the last year has shown that we need to fight for our democracy. “Freedom is not free” is a pithy phrase that usually refers to the sacrifices of our military against external threats. It turns out that same slogan can be applied to challenges which are closer to home. We need to stand up for our values, defend our institutions, participate in civil society and support a free press. Every citizen doesn’t need to do everything, but each one of us can do one thing. And every day, I see American citizens around me doing just that: reanimating the Constitution and the values it represents. We do this even when the odds seem against us, even when wrongdoers seem to be rewarded, because it is the right thing to do.

I had always thought that our institutions would forever protect us against individual transgressors. But it turns out that our institutions need us as much as we need them; they need the American people to protect them or they will be hollowed out over time, unable to serve and protect our country.

Read in full:

Afghanistan Papers: A secret history of the war #hardreading

 

 

WaPo Editorial Board: Pompeo is enabling the destruction of U.S. diplomacy

 

Via WaPo Editorial Board:

Mr. Pompeo listened on July 25 while Mr. Trump pressed Ukrainian President Volodymyr Zelensky to investigate that theory as well as the false story that Mr. Biden sought the removal of a Ukrainian prosecutor to protect his son. He listened while Mr. Trump slandered the former U.S. ambassador to Ukraine, Marie Yovanovitch — a dedicated Foreign Service professional — whose tour in Kiev Mr. Pompeo had cut short.
[…]
Mr. Pompeo’s claim that the conversation was “in the context” of long-standing U.S. policy is demonstrably false.

So, too, was Mr. Pompeo’s assertion that a request by House committees for depositions from Ms. Yovanovitch and other State Department officials was improper. Mr. Pompeo claimed the committees had not followed proper procedure or given the officials enough time to prepare. He insisted that State Department lawyers must be present at all depositions to prevent the disclosure of “privileged information.” The House committee chairmen correctly interpreted this bluster: Mr. Pompeo, they said, was “intimidating Department witnesses in order to protect himself and the President.”

Fortunately, one of those witnesses, former special envoy to Ukraine Kurt D. Volker, is due to testify on Thursday, and Ms. Yovanovitch has reportedly been scheduled for next week. They and other State Department professionals should not hesitate to tell Congress the truth about how Mr. Pompeo enabled the destruction of U.S. diplomacy.

Give this guy the “One Team” Award!

Ex-Amb. to Estonia James D. Melville Writes Why He Quit

 

On June 29, U.S. Ambassador to Estonia James Melville announced on Facebook his intent to retire from the Foreign Service after 33 years of public service. See US Ambassador to Estonia James Melville Pens Resignation on FB Over Trump Policies.  On October 3, WaPo published his op-ed explaining his departure.

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Former Ambassador John Feeley’s Parting Shot: Why I could no longer serve this president

Posted: 4:25 am ET

 

Via WaPo:

I never meant for my decision to resign to be a public political statement. Sadly, it became one.

The details of how that happened are less important than the demoralizing take-away: When career public servants take an oath to communicate dissent only in protected channels, Trump administration officials do not protect that promise of privacy.

Leaking is not new in Washington. But leaking a sitting ambassador’s personal resignation letter to the president, as mine was, is something else. This was a painful indication that the current administration has little respect for those who have served the nation apolitically for decades. […] A part of my resignation letter that has not been quoted publicly reads: “I now return home, with no rank or title other than citizen, to continue my American journey.” What this means for me is still evolving.

As the grandson of migrant stock from New York City, an Eagle Scout, a Marine Corps veteran and someone who has spent his diplomatic career in Latin America, I am convinced that the president’s policies regarding migration are not only foolish and delusional but also anti-American.

Read in full below:

Here are a couple of goodbye videos from Panama:

 

Related posts:

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WaPo’s Dana Milbank Goes Scooby-Doo Slap-A-Lympics on Tillerson – Holy Bow Wow!

Posted: 3:41 am ET
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I know,  I know, the world is ending again this month, so what the heck, here is a cute one for all dog lovers and pals out there.

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Russia Seeks Return of Diplomatic Property ASAP, Get Ready For Season Finale!

Posted: 1:04 am ET
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Last December, in response to Russia’s interference in the U.S. election and to a pattern of harassment of our diplomats overseas, the State Department declared persona non grata  35 Russian officials operating in the United States “who were acting in a manner inconsistent with their diplomatic or consular status.” The Department also informed the Russian Government that it would “deny Russian personnel access to two recreational compounds in the United States owned by the Russian Government.” (see USG Declares 35 Russian Officials Persona Non Grata, Imposes New Sanctions).

Last week, the Russian Embassy in D.C. tweeted that it is seeking the return of its diplomatic property ASAP.

WaPo reported on Wednesday that the Trump Administration was moving to return the Russian compounds in Maryland and New York.

Early last month, the Trump administration told the Russians that it would consider turning the properties back over to them if Moscow would lift its freeze, imposed in 2014 in retaliation for U.S. sanctions related to Ukraine, on construction of a new U.S. consulate on a certain parcel of land in St. Petersburg.

Two days later, the U.S. position changed. Secretary of State Rex Tillerson told Russian Foreign Minister Sergei Lavrov and Russian Ambassador Sergey Kislyak at a meeting in Washington that the United States had dropped any linkage between the compounds and the consulate, according to several people with knowledge of the exchanges.

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AFSA Elections 2017: Three of Four Top Elected Posts Are Uncontested. Again.

Posted: 12:10 am ET
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It’s that time of year again. AFSA is having an election for the 2017 Governing Board.  For the second time in four years, three of the four top elected posts are again, unopposed: President, Secretary, Treasurer.  As in 2013, only the State VP position has two candidates.  Also uncontested slots are: USAID VP, FAS VP, APHIS Rep, BBG Rep, FAS Rep and USAID Rep.  The Foreign Service had seen this movie before in the 2013 elections.

Barbara Stephenson is running unopposed for reelection as AFSA’s president. In her latest FSJ column addressing the 30% funding cut, she writes that she has become over the years, a “cheerleader for making the most of transitions to reexamine priorities.” In hedging off potential criticisms for AFSA’s noticeable silence over these budget cuts, she cites “AFSA’s record-high membership levels and the response and feedback from our “structured conversations” (now in their second year) and other communications tell me that many members are open to a sophisticated approach by AFSA that draws on our core competencies as diplomats.”

Following Secretary Tillerson’s recent address to State Department employees, WaPo’s Joe Davidson writes“Tillerson seems more in touch with the tension reorganization can generate among employees than the union representing them. A statement from American Foreign Service Association President Barbara Stephenson didn’t address worker apprehension as she said “this reorganization effort offers a rare opportunity to make American diplomacy stronger.”

Former Ambassador Tom Boyatt running unopposed for AFSA Secretary says in his campaign message that he “registered the unprecedented uncertainties in the current budget proposal, the reorganization and “streamlining” being considered and the possible RIF flowing therefrom.”

First time candidate for AFSA office, former Ambassador Tony Wayne running in an uncontested seat for the Treasurer slot says that he “cannot recall a period when the misunderstanding was so serious regarding the vital role that American diplomats and American diplomacy play.  AFSA must be as effective as possible in explaining the importance of the non-military tools in America’s international policy. The proposed budget cuts are deeply concerning.” 

Ken Kero-Mentz running for State Vice President under the Stephenson slate writes, “I believe we must forge new alliances, build new bridges, and plan for a stronger future, together. […] I believe AFSA must be a place where everyone can share concerns and ideas, safely. I know how to work with senior management, and I know how to advocate for our Foreign Service and our Department.”

Joe De Maria, an independent running for State Vice President says, “I have served 26 years in the Foreign Service. I’ve served at six posts and in five functional bureaus with many fine generalists and specialists. I’ve served as a consular officer, a Pearson Fellow, HRO, Labor Officer and Congressional Advisor. I know the Department well.[…] I know what works well and what doesn’t, and what motivates us to keep plugging away year after year. Let me put this experience and knowledge to work for you and your families.”

Ann Posner for USAID Vice President in an uncontested seat writes: “As USAID Contingency VP, I want to press onward to assure that the Agency streamlines systems that affect FSOs’ work and careers.”

Daniel Crocker running for FCS Vice President as part of the sole slate: “I’ll help ensure that FCS’s role in promoting U.S. economic security is a core component of your country team at post. I’ll challenge Commerce to support a first-tier Foreign Service. And my communication with you will be transparent and timely.”

Independent Steve Morrison is running for FCS Vice President says that he “Cannot be promoted, SFS “window” not open so ONLY WORKS FOR YOU AND YOUR INTERESTS!”

The contested Retiree VP slot is between Bill Haugh who is running as part of the only slate and John Naland running as an independent. Haugh writes: “I want to strengthen AFSA’s capacity to help you transition to retirement. Every retirement is unique, so I propose to strengthen AFSA casework. I am a career management officer with decades of experience navigating the bureaucracy.”

AFSA President twice and former AFSA VP John Naland writes that he is the “only retiree candidate who has pledged to dedicate 20 hours per week to AFSA, I have the time to apply my experience and knowledge to advancing AFSA’s agenda.  As an independent candidate, if the need arises to urge our AFSA President to speak out more strongly in defense of the Service, I will be freer to do so than her fellow slate candidates whose elections she made possible.”

As an aside — we have not made a habit of endorsing AFSA candidates and we are not about to start now, but we will always remember John Naland as an AFSA president who was willing to address members’ concerns long before we had this blog. He was accommodating and sensitive to the issues of Foreign Service members and their spouses, even those who were not paying members of the organization.  He certainly talked the talk and walked the walk.

Frankly, we are sorry to see that he is not at the top of the ticket.

Former Ambassador Alphonse F. La Porta for Retiree Representative talks about “another and lesser known threat: the gutting of employee rights and the labor-management system for which AFSA is responsible as the exclusive representative of the Foreign Service. The law-based and carefully-negotiated rights of federal unions are under attack on the Hill to limit due process, employee protections, and AFSA advocacy.”

Philip A. Shull for Retiree Representative as part of the sole slate writes that “If elected as your Retiree Representative, I will use my skills and 30+ years of experience in marketing and coalition building to win over even more converts.”

George Colvin is running as an independent for Retiree Representative. In his campaign statement, he writes:

According to prominent legal theorist Jack Goldsmith, the Trump administration is conducting “the greatest presidential onslaught on international law and international institutions in American history,” including “trying to gut State Department capacity across the board.” News stories feature bewildered Department staff fearful of budget cuts that could produce a Foreign Service RIF, as well as a drastic and damaging reorganization. The Secretary is a taciturn recluse and policy bystander.

Faced with conditions that threaten both the national interest and the future of the Foreign Service, Barbara Stephenson and her colleagues have nothing to say.

I am running as an independent candidate for retiree representative because I believe AFSA must engage on these concerns, and must be seen to do so. We are the Foreign Service, not the Silent Service; and it is past time for the “Voice of the Foreign Service” to start speaking.

Oh boy! Mr. Colvin might just stir things up on the Board!

Several folks are also running for State Representatives. Some candidates’ statements do not talk about what they hope to accomplish  as AFSA representatives but about the um… “true appreciation of the work” of AFSA President Ambassador Stephenson or Stephenson’s “leadership.”  

Below is a list of nominees.

 

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