David A. Kessler Explained

Names:David A. Kessler
Office:Head of Operation Warp Speed
Term Start:January 20, 2021
Term End:February 24, 2021
President:Joe Biden
Predecessor:Moncef Slaoui
Successor:Gustave F. Perna (Chief Operating Officer of COVID-19 Response for Vaccine and Therapeutics)
Office1:Co-Chair of the COVID-19 Advisory Board
Alongside1:Vivek Murthy and Marcella Nunez-Smith
President1:Joe Biden
Term Start1:November 9, 2020
Term End1:January 20, 2021
Predecessor1:Office established
Successor1:Office abolished
Office2:17th Commissioner of Food and Drugs
President2:George H. W. Bush
Bill Clinton
Term Start2:November 8, 1990
Term End2:February 28, 1997
Predecessor2:Frank Young
Successor2:Jane E. Henney
Birth Name:David Aaron Kessler
Birth Date:13 May 1951
Birth Place:New York City, U.S.
Education:Amherst College (BA)
University of Chicago (JD)
Harvard University (MD)

David Aaron Kessler (born May 13, 1951) is an American pediatrician, attorney, author, and administrator (both academic and governmental) serving as Chief Science Officer of the White House COVID-19 Response Team since 2021. Kessler was the commissioner of the Food and Drug Administration (FDA) from November 8, 1990, to February 28, 1997. He co-chaired the Biden-Harris transition’s COVID-19 Advisory Board from November 2020 to January 2021 and was the head of Operation Warp Speed, the U.S. government program to accelerate the development of COVID-19 vaccines and other treatments, from January to February 2021.[1] [2]

Background

After graduation from Amherst College in 1973, Kessler studied medicine at Harvard University, obtaining an M.D. degree in 1979. While at Harvard, Kessler obtained a J.D. degree in 1977 from the University of Chicago Law School.[3] While serving his residency in pediatrics at Johns Hopkins Hospital in Baltimore, he worked as a consultant to Republican senator Orrin Hatch from Utah, particularly on issues relating to the safety of food additives, and on the regulation of cigarettes and tobacco. From 1984 to 1990, Kessler simultaneously ran a 431-bed teaching hospital in New York City and taught at the Columbia Law School and the Albert Einstein College of Medicine.

As FDA commissioner

Although his appointment as FDA commissioner in 1990 by President George H. W. Bush won bipartisan approval, many of Kessler's actions were controversial, and he soon became more popular with Democrats than Republicans. He moved quickly to make the agency more efficient, reducing the time needed to approve or reject new drugs, including AIDS drugs, and more vigilant in protecting consumers against unsafe products and inflated label claims. It was also on his watch that FDA enacted regulations requiring standardized Nutrition Facts labels on food. In one memorable action, he had 24,000 gallons of Citrus Hill orange juice seized because, although made from concentrate, it was labeled "fresh."[4] Kessler was reappointed to the post of FDA Commissioner during the administration of Bill Clinton.[5]

Kessler is also known for his role in the FDA attempt to regulate cigarettes,[6] which resulted in the FDA v. Brown & Williamson Tobacco Corp. case. The Supreme Court ultimately ruled that the FDA did not have the power to enact and enforce the regulations in question.[7] He was awarded the Public Health Hero award on April 2, 2008, by the UC Berkeley School of Public Health for his work in tobacco regulation. Kessler published a book entitled A Question of Intent, which gave his view of his time at the FDA, focusing on his attempts to change tobacco legislation and the interpretation of that legislation, and his battle with the then-illegal, but still used Y1 strain of tobacco.[6]

Kessler also oversaw the FDA-directed moratorium on silicone breast implant devices in 1992. This moratorium led to a deluge of lawsuits in the following months, many of which were filed prior to the federal judiciary's adoption of the Daubert standard for expert testimony in 1993. These lawsuits ultimately led to perhaps the largest settlement in the history of medical devices, Dow Corning's declaration of bankruptcy, and ongoing payments to individuals for conditions that have nothing to do with silicone. Scientific panels funded by three different government agencies conducted comprehensive assessments and later arrived independently at the same conclusion: that there was no connection between silicone gel implants and systemic disease.[8] [9] [10] The FDA moratorium was lifted in 2006.

After the FDA

Kessler left the FDA to join the Yale School of Medicine as dean from 1997 to 2003. He was awarded the Public Welfare Medal from the National Academy of Sciences in 2001.[11] In 2003 he was recruited to a post as dean and vice-chancellor at the University of California, San Francisco Medical School.[3] [12] After his arrival at UCSF, Kessler uncovered multiple spreadsheets for the same closed fiscal year (a year prior to his recruitment), all showing different revenue and expense numbers, but indicating that the dean's office was in deficit and would continue to be so, in direct contravention of what had been reported to him during his recruitment, evidence of, at best, inadequate financial controls. J. Michael Bishop, Chancellor of UCSF, stated UC audits found no evidence of financial irregularities and, in June 2007, Bishop demanded Kessler's resignation. On December 13, 2007, Kessler was formally dismissed. Bishop then acknowledged that the financial data presented to Kessler during his recruitment might have been misleading. Kessler alleged he was fired for whistleblowing.[13] [14] [15] [16] Subsequent to Kessler's firing, after UCSF was pressured by KPMG to release one of the audits,[17] it was revealed that Kessler had been correct.[18]

His 2009 book entitled The End of Overeating (a New York Times best seller), highlights for the consumer the amount of fat, salt, and sugar in their food intake. He asserts that this trio of elements in restaurant and processed foods conditions us to eat more, in a manner that changes our brain circuitry, and that children may develop a pattern of overeating and obesity that they might retain for life.[19] He stresses that this outcome of lifelong obesity is not genetic, but environmental and avoidable.

On November 9, 2020, Kessler was announced as one of the three co-chairs of president-elect Joe Biden's COVID-19 Advisory Board, alongside former U.S. Surgeon General Vivek Murthy and Yale public health professor Marcella Nunez-Smith.[20] Days later, Kessler was named a candidate for United States Secretary of Health and Human Services in the Biden Administration.[21] Kessler also served as chief medical adviser to the Biden Inaugural Committee, which organized Biden's 2021 presidential inauguration.[22]

On January 15, 2021, the Biden administration announced that it had chosen Kessler to lead Operation Warp Speed, the program to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines and other related treatment.[2]

Selected publications

Notes and References

  1. News: Biden transition team announces coronavirus advisers, including whistleblower Rick Bright. Mucha. Sarah. November 9, 2020. CNN. 9 November 2020.
  2. News: Kaplan. Sheila. January 15, 2021. Biden Picks Former F.D.A. Chief to Lead Federal Vaccine Efforts. New York Times. January 15, 2021.
  3. Web site: David A. Kessler, MD . 2007-12-16 . 2004-06-14 . BIO (Annual International Convention) 2004 Newsroom . https://web.archive.org/web/20070927222933/http://www.bio.org/events/2004/media/brunch/kessler.asp . 2007-09-27.
  4. News: Citing Labels, U.S. Seizes Orange Juice. Leary. Warren E.. 1991-04-25. The New York Times.
  5. News: Clinton Retains Bush Appointee As F.D.A. Chief. Hilts. Philip J.. 1993-02-27. The New York Times.
  6. Book: Kessler, David A.. A Question of Intent: A Great American Battle with a Deadly Industry. registration. Public Affairs. 2001. 1-58648-121-5.
  7. Web site: FDA V. BROWN & WILLIAMSON TOBACCO CORP. Cornell University Law School.
  8. Independent Review Group, Silicone Breast Implants: The Report of the Independent Review Group 8 (July 1998).
  9. Book: Institute of Medicine (US) Committee on the Safety of Silicone Breast Implants . Bondurant . Stuart . Ernster . Virginia . Herdman . Roger . Safety of Silicone Breast Implants . 1999 . National Academies Press (US) . Washington, DC . 10.17226/9602 . 20669503 . 978-0-309-15740-7 . 8 December 2020 . en.
  10. Diamond B, Hulka B, Kerkvliet N, Tugwell P, Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction: A Report by a National Science Panel to the Honorable Sam C. Pointer Jr., Coordinating Judge for the Federal Breast Implant Multi-District Litigation. November 30, 1998.
  11. Web site: Public Welfare Award . National Academy of Sciences . 18 February 2011 . dead . https://web.archive.org/web/20110604024100/http://www.nasonline.org/site/PageServer?pagename=AWARDS_pwm . June 4, 2011 .
  12. Web site: Recruited from Yale with money, gifts and promises. Schevitz. Tanya. 2007-12-15. www.sfgate.com. San Francisco Chronicle. A12. 2007-12-16.
  13. News: UCSF medical school fires dean in dispute over finances. Russell. Sabin. 2007-12-15. www.sfgate.com. San Francisco Chronicle.
  14. Web site: UCSF Issue Statement About Leadership Changes at UCSF School of Medicine. 2007-12-14. UCSF. https://web.archive.org/web/20080119133803/http://pub.ucsf.edu/today/cache/news/200712144.html. 2008-01-19.
  15. Miller. Greg. 2007-12-21. UNIVERSITIES: Questions Swirl Around Kessler's Abrupt Dismissal From UCSF. Science. en. 318. 5858. 1855a. 10.1126/science.318.5858.1855a. 18096782. 43580146. 0036-8075.
  16. News: UCSF dean is fired, cites whistle-blowing. Los Angeles Times.
  17. News: UCSF Refuses to Release Outside Review of Finances. Schevitz. Tanya. January 16, 2008. San Francisco Chronicle. Russell. Sabin.
  18. News: Audit Firm Sides With Ex-Dean of University of California-San Francisco Medical School. The Chronicle of Higher Education. February 5, 2008.
  19. News: Crave Man: David Kessler Knew That Some Foods Are Hard to Resist; Now He Knows Why. The Washington Post.
  20. Web site: Feuer. Will. 2020-11-07. President-elect Joe Biden announces Covid task force. 2020-11-09. CNBC. en. article updated: 12:50 UCT 2020-11-09.
  21. News: Who Are Contenders for Biden's Cabinet? . 11 November 2020 . The New York Times . 11 November 2020.
  22. News: Inauguration Day, From Home: Biden Team Plans Celebration Amid COVID-19. 16 December 2020 . . 15 December 2020.