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Robert Kadlec
Assistant Secretary of Health and Human Services for Preparedness and Response
In office
August 18, 2017 – January 20, 2021
PresidentDonald Trump
Preceded byGeorge Korch (Acting)
Succeeded byNikki Bratcher-Bowman (Acting)
Dawn O’Connell
Personal details
Bornapprox. 1957[citation needed]
Political partyRepublican
EducationUnited States Air Force Academy (BS)
Uniformed Services University of the Health Sciences (MD)
Georgetown University (MS)

Robert Peter Kadlec[1] (/ˈkædlɪk/ KAD-lik[2]) is an American physician and career officer in the United States Air Force who served as Assistant Secretary of Health and Human Services (Preparedness and Response) from August 2017 until January 2021. He is responsible for the creation of the COVID-19 vaccine development program Operation Warp Speed.

Early life[edit]

Kadlec graduated with a B.S. from the United States Air Force Academy in 1979, an M.D. from the Uniformed Services University of the Health Sciences in 1983, and an M.A. from Georgetown University in 1989.[3]

Career[edit]

Kadlec spent 26 years as a career officer and physician in the United States Air Force. He was awarded the Bronze Star Medal for service in Iraq. In the White House Homeland Security Council, Kadlec was Director for Biodefense and Special Assistant to President George W. Bush for Biodefense Policy from 2007 to 2009.[3][4]

Kadlec was Deputy Staff Director for the United States Senate Select Committee on Intelligence when he was nominated by President Donald Trump to become Assistant Secretary for Preparedness and Response (ASPR), an office within Health and Human Services.[5] Kadlec was confirmed for this position by the United States Senate on August 3, 2017,[6] by voice vote.[7]

Office of Preparedness and Response[edit]

In January 2018, Kadlec testified to the U.S. Congress that the US was dangerously unprepared for a pandemic.[8] Prior to the COVID-19 pandemic, Kadlec had heavily focused the office on preparing for a response to bioterror attacks, a choice that was later scrutinized.[9] From January through March 2020, Kadlec and his team focused on evacuating U.S. nationals from cruise ships and countries hard-hit by the pandemic; Kadlec's defenders said that this focus was necessary to protect Americans, while detractors criticized him for missing opportunities to prepare for pandemic COVID-19 in the United States.

In April 2020, Kadlec demoted federal scientist Rick Bright, removing him from his position as head of the Biomedical Advanced Research and Development Authority (BARDA) and reassigning him to a lower post at the National Institutes of Health. The following month, Bright filed a wide-ranging whistleblower complaint against Kadlec and several Trump administration officials.[10][9] Bright asserted that Kadlec ousted him in retaliation for his "insistence" that the federal government focus resources on "safe and scientifically vetted solutions" against the COVID-19 pandemic rather than "technologies that lack scientific merit" such as the use of hydroxychloroquine, which had been pushed by the Trump administration.[9] Bright also alleged that in January 2020, Kadlec had delayed acting to obtain face masks, testing swabs, and other materials for which there was later a shortage.[9] Supporters of Bright and supporters of Kadlec each accused the other "of preferential treatment for favored contractors and inappropriate spending decisions."[9] HHS denied that Bright had been retaliated against, but the Office of Special Counsel recommended Bright's reinstatement as BARDA chief,[9][10] finding a "substantial likelihood of wrongdoing" in his ouster.[10]

Creation of Operation Warp Speed[edit]

Kadlec is responsible for creating the COVID-19 vaccine development program named Operation Warp Speed (OWS). In April 2020, Kadlec worked with Peter Marks (physician), director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) to develop OWS. Kadlec and Marks wrote a proposal for then Secretary of the Department of Health and Human Services (HHS) Alex Azar detailing how Operation Warp Speed would screen potential vaccine candidates and eventually distribute final product to all Americans. [11]

A memo circulated by Kadlec and Marks to Azar on April 12 was the first detailed accounting of OWS’ goals: [12]

"Project Warp Speed
Maximally expediting a safe, effective vaccine
A safe, effective, broadly administered vaccine is the single most important solution to the Covid-19 pandemic
MISSION: Maximally expedite the development of a safe and effective vaccine with sufficient scale to inoculate all Americans who need it
DEADLINE: Enable broad access to the public by October 2020
PLAN: Modeled after the Manhattan Project approach, a multi-disciplinary, multi-sector team that brings the numerous in-flight efforts under a single authority to drive relentless coordination, barrier elimination, and accountability for mission success"

Kadlec was responsible for setting the aggressive deadline of October 2020 to complete simultaneous clinical trials and roll out the vaccine to the American public.[12] Recognizing the national security importance of OWS, Azar and Kadlec also worked to enlist the Department of Defense (DoD) as a key partner in both the science and the logistics.[12]

While OWS was initially named “Project Warp Speed,” Kadlec would later rename it to “Operation Warp Speed” to better reflect the role DoD would play.[12] On April 24, 2020, Kadlec approved the first communications between FDA and companies who would eventually partner with the government to successfully develop and distribute COVID-19 vaccines.[12] OWS was announced to the public on May 15, 2020.[13]

Emergent BioSolutions controversies[edit]

Before being appointed by Trump as Assistant Secretary for Preparedness and Response in 2017, Kadlec previously was a consultant for Emergent BioSolutions, a U.S. biotechnology company, and was part-owner of a consulting company related to its founder; he did not disclose these facts in Senate nomination forms during his 2017 confirmation process.[14] According to HHS, Kadlec may not have realized that his involvement in the start-up could be characterized as one of employment. Kadlec's company RPK Consulting had provided consulting services to Emergent until 2015.[15] Soon after taking office, Kadlec pushed to increase the government's stockpile of smallpox vaccine from Emergent BioSolutions, and HHS ultimately awarded a 10-year, $2.8 billion single-source contract to the company to purchase its smallpox vaccines at twice the previous price.[14][16] While renewal of the contract was initially sought on modest terms, Kadlec's office finalized the deal with double the term length (10 years instead of 5 years) and double the number of doses per year (to 18 million). This raised concerns about a potential conflict of interest.[9][14]

After 15 million Janssen COVID-19 vaccines were ruined due to an error by Emergent BioSolutions (who held a contract to manufacture the vaccines at a Baltimore production facility), a congressional investigation was launched "into whether Emergent used ties to the Trump administration to get billions of dollars in federal contracts despite a history of failing to complete contracts" as well as concerns about "inadequate staff training, persistent quality-control issues, and the company's 'unjustified' 800% price increase for an anthrax vaccine" purchased by the government.[17][15] The inquiry, launched by the Democratic chairs of the House Committee on Oversight and Reform and Select Oversight Subcommittee on the Coronavirus Crisis, focused in part on Kadlec's role; in a letter, the chairs of the committee wrote that Kadlec "appears to have pushed for" the $628 million award to Emergent to develop the factory "despite indications that Emergent did not have the ability to reliably fulfill the contract."[17][15] The inquiry was not pursued any further.

References[edit]

  1. ^ Commencement Exercises. Bethesda, Maryland: The Uniformed Services University of the Health Sciences School of Medicine. May 21, 1983. Retrieved 2021-06-27.
  2. ^ "Tell Me More About Vaccines | How Vaccines are Developed". YouTube. Oct 6, 2020. Retrieved 15 March 2023.
  3. ^ a b "Robert Kadlec, MD, MS". Stanford Medicine. Retrieved 7 August 2017.
  4. ^ "Facing 21st Century Public Health Treats : Our Nation's Preparedness and Response Capabilities, Part 1 Statement of Robert Kadlec, MD, MTM&H, MS Assistant Secretary for Preparedness and Response" (PDF). Help.senate.gov. Retrieved 15 June 2019.
  5. ^ "President Donald J. Trump Announces Key Additions to his Administration". whitehouse.gov. July 10, 2017. Retrieved 7 August 2017 – via National Archives.
  6. ^ Ault, Alcia (August 3, 2017). "HHS Picks". MedScape. Retrieved 7 August 2017.
  7. ^ PN744 — Robert P. Kadlec — Department of Health and Human Services, Congress.gov.
  8. ^ "Inside Operation Warp Speed's $26b sprint for a vaccine". Australian Financial Review. 2020-11-10. Retrieved 2021-04-22.
  9. ^ a b c d e f g Diamond, Dan (13 May 2020). "Colleagues paint a mixed picture of ousted vaccine chief". POLITICO. Retrieved 2021-04-14.
  10. ^ a b c Nicholas Florko, Trump administration fires back at ousted vaccine expert as he testifies on his role in U.S. coronavirus response, Stat News (May 14, 2020).
  11. ^ How the ‘deep state’ scientists vilified by Trump helped him deliver an unprecedented achievement, Washington Post (December 14, 2020).
  12. ^ a b c d e Inside the Messy Race to Develop a COVID Vaccine, Esquire (October 19, 2021).
  13. ^ Trump announces 'Operation Warp Speed,' says U.S. could have coronavirus vaccine by January, USA Today (May 15, 2020).
  14. ^ a b c Jon Swaine, Robert O'Harrow Jr. & Aaron C. Davis (May 4, 2020). "Before pandemic, Trump's stockpile chief put focus on biodefense. An old client benefited". Washington Post.
  15. ^ a b c Mendez, Rich (2021-04-20). "Congressional investigation launched into Emergent BioSolutions' federal vaccine contracts". CNBC.com. Retrieved 2021-04-22.
  16. ^ Flax, Debra (2019-09-03). "HHS awards 10-year contract to Emergent BioSolutions for smallpox vaccine". Homeland Preparedness News. Retrieved 2019-10-05.
  17. ^ a b Mole, Beth (2021-04-22). "Contractor that ruined 15M doses of J&J vaccine hiked price of another by 800%". ArsTechnica. Retrieved 2021-04-22.

External links[edit]

source: https://en.wikipedia.org/wiki/Robert_Kadlec