Embedded Files
2019 (Feb) 2019-02-thefix-com-former-commissioner-blames-fda-opioid-crisis-no-one-stopped-it-profile-kessler.jpghttps://www.thefix.com/former-commissioner-blames-fda-opioid-crisis-no-one-stopped-it2019-02-thefix-com-former-commissioner-blames-fda-opioid-crisis-no-one-stopped-it.pdf2019-02-thefix-com-former-commissioner-blames-fda-opioid-crisis-no-one-stopped-it-img-1.jpg
Saved Wikipedia (Nov 11, 2021) - "David A. Kessler"
Saved Wikipedia (Nov 11, 2021) - "David A. Kessler"
https://en.wikipedia.org/wiki/David_A._Kessler
2021-11-11-wikipedia-org-david-a-kessler.pdf
Head of Operation Warp Speed
In office
January 20, 2021 – February 24, 2021
President
Preceded by
Succeeded by
Gustave F. Perna (Chief Operating Officer of COVID-19 Response for Vaccine and Therapeutics)
Co-Chair of the COVID-19 Advisory Board
In office
November 9, 2020 – January 20, 2021
Serving with Vivek Murthy and Marcella Nunez-Smith
President
Preceded by
Office established
Succeeded by
Office abolished
17th Commissioner of Food and Drugs
In office
November 8, 1990 – February 28, 1997
President
Preceded by
Succeeded by
Personal details
Born
David Aaron Kessler
May 13, 1951 (age 70)
New York City, New York, U.S.
Education
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 treatment, from January to February 2021.[1][2]
Background
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.[citation needed]
As FDA commissioner
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 under 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.[citation needed]
After the FDA
After the FDA
Kessler delivers a lecture at George Washington University in October 2013
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, claimed 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.[citation needed]
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
Selected publications
Kessler, David A., Fast Carbs, Slow Carbs: The Simple Truth About Food, Weight, and Disease (2020) ISBN 9780062996978
Kessler, David A., Capture: Unraveling the Mystery of Mental Suffering (2016) ISBN 9780062388513
Kessler, David A., Your Food Is Fooling You: How Your Brain Is Hijacked by Sugar, Fat, and Salt (2012) ISBN 9781596438316 (A version of The End of Overeating aimed at teens)
Kessler, David A., The End of Overeating: Taking Control of the Insatiable American Appetite (2009) ISBN 1-60529-785-2
Kessler, David A., A Question of Intent: A Great American Battle with a Deadly Industry (2001) ISBN 1-891620-80-0
Kessler, David A.; Rose, Janet L.; Temple, Robert J.; Schapiro, Renie; Griffin, Joseph P. (1994). "Therapeutic-Class Wars -- Drug Promotion in a Competitive Marketplace". New England Journal of Medicine. 331 (20): 1350–1353. doi:10.1056/NEJM199411173312007. ISSN 0028-4793. PMID 7935706.
Eisdorfer, Carl, David A. Kessler, and Abby N. Spector, eds. Caring for the Elderly: Reshaping Health Policy (1989) ISBN 978-0-8018-3810-1
References
References
^ Mucha, Sarah (November 9, 2020). "Biden transition team announces coronavirus advisers, including whistleblower Rick Bright". CNN. Retrieved 9 November 2020.
a b Kaplan, Sheila (January 15, 2021). "Biden Picks Former F.D.A. Chief to Lead Federal Vaccine Efforts". New York Times. Retrieved January 15, 2021.
a b "David A. Kessler, MD". BIO (Annual International Convention) 2004 Newsroom. 2004-06-14. Archived from the original on 2007-09-27. Retrieved 2007-12-16.
^ Leary, Warren E. (1991-04-25). "Citing Labels, U.S. Seizes Orange Juice". The New York Times.
^ Hilts, Philip J. (1993-02-27). "Clinton Retains Bush Appointee As F.D.A. Chief". The New York Times.
a b Kessler, David A. (2001). A Question of Intent: A Great American Battle with a Deadly Industry. Public Affairs. ISBN 1-58648-121-5.
^ "FDA V. BROWN & WILLIAMSON TOBACCO CORP". Cornell University Law School.
^ Independent Review Group, Silicone Breast Implants: The Report of the Independent Review Group 8 (July 1998).
^ Institute of Medicine (US) Committee on the Safety of Silicone Breast Implants (1999). Bondurant, Stuart; Ernster, Virginia; Herdman, Roger (eds.). Safety of Silicone Breast Implants. Washington, DC: National Academies Press (US). Retrieved 8 December 2020.
^ 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.
^ "Public Welfare Award". National Academy of Sciences. Archived from the original on June 4, 2011. Retrieved 18 February 2011.
^ Schevitz, Tanya (2007-12-15). "Recruited from Yale with money, gifts and promises". www.sfgate.com. San Francisco Chronicle. p. A12. Retrieved 2007-12-16.
^ Russell, Sabin (2007-12-15). "UCSF medical school fires dean in dispute over finances". www.sfgate.com. San Francisco Chronicle.
^ "UCSF Issue Statement About Leadership Changes at UCSF School of Medicine". UCSF. 2007-12-14. Archived from the original on 2008-01-19.
^ Miller, Greg (2007-12-21). "UNIVERSITIES: Questions Swirl Around Kessler's Abrupt Dismissal From UCSF". Science. 318 (5858): 1855a. doi:10.1126/science.318.5858.1855a. ISSN 0036-8075. PMID 18096782. S2CID 43580146.
^ "UCSF dean is fired, cites whistle-blowing". Los Angeles Times.
^ Schevitz, Tanya; Russell, Sabin (January 16, 2008). "UCSF Refuses to Release Outside Review of Finances". San Francisco Chronicle.[permanent dead link]
^ "Audit Firm Sides With Ex-Dean of University of California-San Francisco Medical School". The Chronicle of Higher Education. February 5, 2008.
^ "Crave Man: David Kessler Knew That Some Foods Are Hard to Resist; Now He Knows Why". The Washington Post.
^ Feuer, Will (2020-11-07). "President-elect Joe Biden announces Covid task force". CNBC (article updated: 12:50 UCT 2020-11-09 ed.). Retrieved 2020-11-09.
^ "Who Are Contenders for Biden's Cabinet?". The New York Times. 11 November 2020. Retrieved 11 November 2020.
^ "Inauguration Day, From Home: Biden Team Plans Celebration Amid COVID-19". NPR. 15 December 2020. Retrieved 16 December 2020.
External links
External links
2019 (Feb)
2019-02-60-minutes-kessler.jpg
https://www.thefix.com/former-commissioner-blames-fda-opioid-crisis-no-one-stopped-it
2019-02-thefix-com-former-commissioner-blames-fda-opioid-crisis-no-one-stopped-it.pdf
2019-02-thefix-com-former-commissioner-blames-fda-opioid-crisis-no-one-stopped-it-img-1.jpg
Former Commissioner Blames FDA For Opioid Crisis: "No One Stopped It"
Former Commissioner Blames FDA For Opioid Crisis: "No One Stopped It"
By Lindsey Weedston 02/27/19
"There are no studies on the safety or efficacy of opioids for long-term use," said former FDA commissioner David Kessler in a recent 60 Minutes interview.
The former Food and Drug Administration commissioner expressed regret that the agency allowed drug companies to promote the idea that opioid painkillers were safe for long-term use in a recent 60 Minutes interview.
Dr. David Kessler was FDA commissioner during the '90s, when Purdue Pharma’s prescription opioid OxyContin was approved. Shortly after, Purdue began an aggressive marketing campaign to both prescribers and consumers, including chronic pain patients.
In 2001, the FDA changed the indication on the label for prescription opioids to say that it was safe for long-term use, allowing drug companies to market them as such. However, Dr. Kessler now says that there were no studies on the long-term effects of regular, ongoing opioid use at the time.
"There are no studies on the safety or efficacy of opioids for long-term use," said Kessler in the interview. "The rigorous kind of scientific research the agency should be relying on is not there."
The former commissioner also appears to regret allowing the methods of the OxyContin marketing campaign, which were unprecedented in the prescription drug market. Soon, companies like Purdue were convincing doctors to prescribe more pills at higher doses—something that experts believe fueled the current epidemic of opioid-related addiction and overdoses.
Dr. Kessler is now on retainer by cities and counties that are suing Purdue Pharma and other drug companies for the damage caused by the opioid crisis. He officially left the FDA before the drugs were proclaimed safe for extended use, but laments that no one stopped it from happening.
“You have a system of pharmaceutical promotion that changed the way medicine practiced and no one, all right, stopped it,” he said. He later blames this on understaffing in the FDA marketing department.
Current FDA Commissioner Dr. Scott Gottlieb declined to be interviewed, instead providing a written statement.
“Many mistakes were made along the way,” it reads. “While the agency followed the law in approving and regulating opioids, we at the FDA include ourselves among those that should have acted sooner.”
On another 60 Minutes segment three days later, drug manufacturer Ed Thompson indicted “his own industry” and agreed with Dr. Kessler’s assessment that the label change was what sparked the opioid epidemic.
“The root cause of this epidemic is the FDA's illegal approval of opioids for the treatment of chronic pain,” Thompson said. “Without question, they start the fire.”
Thompson himself is now suing the FDA in an attempt to force the agency to change the labeling on prescription opioids once again to say that it’s only safe for short-term use. As a maker of these drugs, he stands to lose billions if he’s successful. Thompson is going ahead with the suit, however, refusing to sell what he calls “snake oil” to consumers.
“You're using high-dose, long-duration opioids when they've never been designed to do that,” he explained. “There's no evidence that they're effective. There's extreme evidence of harms and deaths when you use them.”
Page updated
Report abuse