David A. Kessler | |
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Head of Operation Warp Speed | |
In office January 20, 2021 –February 24, 2021 | |
President | Joe Biden |
Preceded by | Moncef Slaoui |
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 Servingwith Vivek Murthy and Marcella Nunez-Smith | |
Preceded by | Office established |
Succeeded by | Office abolished |
16th Commissioner of Food and Drugs | |
In office November 8,1990 –February 28,1997 | |
President | George H. W. Bush Bill Clinton |
Preceded by | Frank Young |
Succeeded by | Jane E. Henney |
Personal details | |
Born | David Aaron Kessler May 13,1951 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]
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 ]
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.[ citation needed ]
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.[ 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]
The University of California, San Francisco (UCSF), is a public land-grant research university in San Francisco, California, United States. It is part of the University of California system and is dedicated entirely to health science and life science. It conducts research and teaching in medical and biological sciences.
Plastic surgery is a surgical specialty involving the restoration, reconstruction, or alteration of the human body. It can be divided into two main categories: reconstructive surgery and cosmetic surgery. Reconstructive surgery covers a wide range of specialties, including craniofacial surgery, hand surgery, microsurgery, and the treatment of burns. This category of surgery focuses on restoring a body part or improving its function. In contrast, cosmetic surgery focuses solely on improving the physical appearance of the body. A comprehensive definition of plastic surgery has never been established, because it has no distinct anatomical object and thus overlaps with practically all other surgical specialties. An essential feature of plastic surgery is that it involves the treatment of conditions that require or may require tissue relocation skills.
Breast augmentation and augmentation mammoplasty is a cosmetic surgery procedure, which uses breast-implants and/ or fat-graft mammoplasty technique to increase the size, change the shape, and alter the texture of the breasts. Although in some cases augmentation mammoplasty is applied to correct congenital defects of the breasts and the chest wall in other cases it is performed purely for cosmetic reasons.
Breast Men is a 1997 American, semibiographical, dark comedy drama film; it was written by John Stockwell and directed by Lawrence O'Neil for HBO.
Capsular contracture is a response of the immune system to foreign materials in the human body. Medically, it occurs mostly in context of the complications from breast implants and artificial joint prosthetics.
A breast implant is a prosthesis used to change the size, shape, and contour of a person's breast. In reconstructive plastic surgery, breast implants can be placed to restore a natural looking breast following a mastectomy, to correct congenital defects and deformities of the chest wall or, cosmetically, to enlarge the appearance of the breast through breast augmentation surgery.
Diana M. Zuckerman is an American health policy analyst who focuses on the implications of policies for public health and patients' health. She specializes in national health policy, particularly in women's health and the safety and effectiveness of medical products. She is the President of the National Center for Health Research and the Cancer Prevention and Treatment Fund.
Stanton Arnold Glantz is an American professor, author, and tobacco control activist. Glantz is a faculty member at the University of California, San Francisco (UCSF) School of Medicine, where he is a Professor of Medicine (retired) in the Division of Cardiology, the American Legacy Foundation Distinguished Professor of Tobacco Control, and former director of the Center for Tobacco Control Research and Education. Glantz's research focused on the health effects of tobacco smoking.
Mentor Worldwide LLC is an American company that supplies surgical aesthetics products to plastic surgeons. The company is based in Santa Barbara, California and is part of Johnson & Johnson MedTech business segment. It produces one of two silicone gel breast implants. Titled MemoryGel, the product was approved by the U.S. Food and Drug Administration (FDA) on November 17, 2006. The other FDA-approved products are developed by competitors Allergan and Sientra. Mentor also produces a range of lipoplasty equipment for liposuction procedures as well as a Niacin-based skincare product line called NIA 24.
Steven C. Parrish is a C-Suite executive consultant, American lawyer, Chair Safe Horizon, and community volunteer. Until 2008, he was an executive for Altria Group Inc. where he was a Senior Vice President for Corporate Affairs.
Medical grade silicones are silicones tested for biocompatibility and are appropriate to be used for medical applications. In the United States, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regulates devices implanted into the body. It does not regulate materials other than certain dental materials. The FDA regulate silicones used in food contact under the auspices of the Center for Food Safety and Nutrition (CFSAN) and for use in pharmaceuticals under the auspices of the Center for Drug Evaluation and Research (CDER).
Susan Kolb is a medical doctor in Atlanta, Georgia, and the author of The Naked Truth about Breast Implants: From Harm to Healing. Her area of specialization is plastic and reconstructive surgery. Kolb is a medical authority on the complications arising from breast implants, and has been an active voice in the debate about the safety of breast implant devices since 1996. She has treated over 2,000 women suffering from breast implant disease and related systemic immune disorders.
The Center for Tobacco Control Research and Education at the University of California, San Francisco, "serves as a focal point for a broad range of research, education, and public service activities for 46 faculty in 11 departments and all 4 schools at UCSF, as well as colleagues at UC Berkeley and UC Merced." It is part of the UCSF Cardiovascular Research Institute. The Center's director and principal investigator is Stanton Glantz, a Professor of Medicine in the Division of Cardiology at UCSF.
Robert McKinnon Califf is an American cardiologist who currently serves as the 25th commissioner of the Food and Drug Administration.
The UCSF School of Medicine is the medical school of the University of California, San Francisco and is located at the base of Mount Sutro on the Parnassus Heights campus in San Francisco, California. Founded in 1864 by Hugh Toland, it is the oldest medical school in California and in the western United States.
Neal L. Benowitz is an American academic physician and professor of medicine at the University of California, San Francisco (UCSF), with expertise on the pharmacology of nicotine and tobacco addiction.
Scott Gottlieb is an American physician, investor, and author who served as the 23rd commissioner of the Food and Drug Administration (FDA) from May 2017 until April 2019. He is presently a senior fellow at the conservative think tank the American Enterprise Institute (AEI), a partner at the venture capital firm New Enterprise Associates (NEA), a member of the board of directors of drug maker Pfizer, Inc and gene sequencing company Illumina, Inc. and a contributor to cable financial news network CNBC and the CBS News program Face the Nation. An elected member of the National Academy of Medicine, Gottlieb is the author of The New York Times best selling book Uncontrolled Spread on the COVID-19 pandemic and the national security vulnerabilities that it revealed. His forthcoming book, The Miracle Century: Making Sense of the Cell Therapy Revolution, traces the scientific achievements that propelled progress in cell therapies.
The COVID-19 Advisory Board was announced in November 2020 by President-elect of the United States Joe Biden as part of his presidential transition. It was co-chaired by physicians David A. Kessler, Marcella Nunez-Smith, and Vivek Murthy and comprises 13 health experts. The board was then succeeded by the White House COVID-19 Response Team upon Biden's presidency in January 2021.
Robert M. Rodriguez is an American emergency physician working at the San Francisco General Hospital. He is a professor of emergency medicine at the UCSF School of Medicine and was a member of the COVID-19 Advisory Board of U.S. president Joe Biden.
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