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Stephen Hahn | |
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24th Commissioner of Food and Drugs | |
In office December 17, 2019 –January 20, 2021 | |
President | Donald Trump |
Preceded by | Scott Gottlieb |
Succeeded by | Janet Woodcock (acting) [1] Robert Califf |
Personal details | |
Born | January 22,1960 |
Education | Rice University (BA) Temple University (MD) |
Stephen Michael Hahn (born January 22,1960) is an American physician who served as the Commissioner of Food and Drugs from 2019 to 2021. Before becoming Commissioner,he was an oncologist serving as Chief Medical Executive of the MD Anderson Cancer Center.
Hahn received a BA in Biology from Rice University in 1980,and an MD from Temple University in 1984. [2] After graduating from medical school,Hahn completed an internal medicine residency at the University of California,San Francisco School of Medicine where he eventually served as chief resident before embarking on a fellowship in medical oncology at the National Institutes of Health (NIH). [3]
After completing his fellowship,Hahn worked as a radiation oncologist in Santa Rosa,California. [4] He was then recruited by his mentor,Dr. Eli J. Glatstein [5] to complete a separate residency in radiation oncology at the NIH between 1991 and 1994,where he eventually attained the rank of commander in the U.S. Public Health Service Commissioned Corps between 1989 and 1995. During the period of 1993–1999,he served as chief of NCI's Prostate Cancer Clinic in the Clinical Pharmacology Branch. [4]
In 1996,Hahn joined the University of Pennsylvania School of Medicine as a radiation and medical oncologist as well as a researcher funded by the National Institutes of Health (NIH). As eventual Vice-Chair for Research in the Department of Radiation Oncology at Penn and Principal Investigator of National Cancer Institute grants,Hahn led the expansion of the Department's research base. [4] In 2013,he was awarded status as a fellow in the American Society for Radiation Oncology (ASTRO). [6] He then held the Department of Radiation Oncology's fourth endowed Henry Pancoast Professorship as Department Chair until 2014. During that time,Hahn assisted with the Department's scandal involving brachytherapy at the Veterans Affairs Hospital in Philadelphia, [7] [8] which was staffed with University of Pennsylvania faculty,all while securing increased research funding during a transition period in 2007-08 into the new Perelman Center for Advanced Medicine Robert's Proton Center,which remains the largest proton therapy center associated with a university teaching hospital in the world. [9] Hahn remains Board Certified in Internal Medicine,Medical Oncology,and Radiation Oncology.
In 2015,Hahn became the chair of radiation oncology at the University of Texas MD Anderson Cancer Center in Houston,where he oversaw the Departments of Clinical Radiation Oncology,Radiation Physics,and Radiation Biology. [10] In 2018,Hahn was appointed as the Chief Medical Executive of MD Anderson Cancer Center. During this period as an active clinician,Hahn specialized in treating thoracic,sarcomatous,and genitourinary cancers,as well as the use of photodynamic therapy for the treatment of pre-invasive and invasive malignancies. [11]
On November 1,2019,U.S. President Donald Trump announced his intent to nominate Hahn to be Commissioner of Food and Drugs Administration. [12] [13] [14] On December 3,2019,the Senate Health Education Labor and Pensions Committee voted 18 to 5 to advance the nomination to the Senate floor. [15] On December 12,2019,the Senate confirmed his nomination by a 72–18 vote. [16] Hahn was sworn in on December 17,2019. [17]
Hahn has factored prominently in the Trump administration's response to the novel coronavirus pandemic in the United States,although the FDA under his administration has also been criticized for a lethargic response to the rapidly emerging outbreak in the United States. [18] By November 2020,Hahn had gained the confidence of individuals concerned about the politicization of the agency. [19]
On March 1,2020,Vice President Mike Pence and Health and Human Services Secretary Alex Azar announced the addition of Hahn to the White House Coronavirus Task Force. [20]
According to a whistleblower complaint filed by HHS infectious disease expert Rick Bright,in April 2020,Hahn instructed FEMA administrator Peter Gaynor "to distribute hydroxychloroquine to pharmacies nationwide," even though the emergency use authorization (EUA) issued by the FDA did not provide for outpatient use of hydroxychloroquine for COVID-19. [21] Hydroxychloroquine was later linked to multiple deaths of COVID-19 patients, [22] and the FDA revoked the EUA in June 2020. [23]
On July 5,2020,Hahn refused to defend Trump's false claim that 99% of coronavirus cases are "totally harmless";in response to an interview question about the president's claim,Hahn said,"I'm not going to get into who is right and who is wrong." [24] [25]
On August 23,2020,Hahn joined with Trump and Azar in announcing an emergency authorization for the use of coronavirus convalescent plasma in treating COVID-19. [26] As with hydroxychloroquine,Trump publicly exerted major pressure on the FDA to approve convalescent plasma as a COVID-19 treatment,even suggesting that "deep state,or whoever over at the FDA" was blocking the authorization. [27] The approval came a few days after Trump publicly complained that the agency was moving too slowly on plasma and suggested they might be delaying the approval for political reasons. In fact,the delay was due to concerns at the National Institutes of Health that the treatment's effectiveness had not been adequately demonstrated. [28] Hahn has said that Trump "has asked FDA to cut back red tape and try to speed medical products into the hands of providers,patients and American consumers." [26] In making the announcement Trump exaggerated plasma's effectiveness compared to the FDA's own assessment,and Hahn did not correct him. [26] After coming under criticism from scientists and former FDA officials for echoing Trump's exaggerated claims about the benefits of convalescent plasma,Hahn issued an apology/correction,saying,"The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction,not an absolute risk reduction." [27] [29]
The FDA was criticized in the beginning stages of the pandemic in the U.S. for moving slowly and bureaucratically in approving COVID-19 tests developed by laboratories,prompting concerns from academic medical centers and others. [30] On February 29,2020,the FDA allowed laboratories to begin using tests after validation,but still required emergency use authorization applications. [30] Over the following months,the FDA approved many COVID-19 tests,including lab-developed and non-lab-developed tests. In August 2020,the Trump administration blocked the FDA from regulating COVID-19 tests and a wide array of other laboratory tests. [30] The move was strongly opposed by Hahn and the FDA,and came after rising tensions between Hahn and Azar. [30] The sudden move was criticized by public health experts,who stated the change could lead to more unreliable or defective coronavirus tests entering the market,and pointed out that testing shortages were by that point primarily attributable to shortages of swabs,chemical reagents,and other supplies,rather than a lack of approved tests. [30]
After controversy over the hydroxychloroquine and plasma authorizations,Hahn transferred two political appointees from the top public relations and communications posts at the agency,replacing them with career civil servants on an acting basis. Emily Miller,the agency's top spokesperson,who had no prior medical or science experience,was removed on August 28 after just two weeks on the job. [31] On September 2 John "Wolf" Wagner,a close ally of chief DHS spokesman Michael Caputo,was removed from his post as FDA's associate commissioner for external affairs after serving for two months. [32]
Hahn left office on January 20,2021. [33] Six months later he assumed the role of chief medical officer of Flagship Pioneering,the venture firm behind Moderna. [34] [35]
Hahn is a member of the American Society of Clinical Oncology,American Society for Radiation Oncology,Radiation Research Society,American Society of Photobiology,American Association for Cancer Research,and the University of Pennsylvania's John Morgan Society. [4]
Hahn has been married for more than 30 years and has four children. [10]
Hydroxychloroquine,sold under the brand name Plaquenil among others,is a medication used to prevent and treat malaria in areas where malaria remains sensitive to chloroquine. Other uses include treatment of rheumatoid arthritis,lupus,and porphyria cutanea tarda. It is taken by mouth,often in the form of hydroxychloroquine sulfate.
Alex Michael Azar II is an American attorney,businessman,lobbyist,and former pharmaceutical executive who served as the United States Secretary of Health and Human Services from 2018 to 2021. Azar was nominated to his post by President Donald Trump on November 13,2017,and confirmed by the United States Senate on January 24,2018. He was also chairman of the White House Coronavirus Task Force from its inception in January 2020 to February 2020,when he was replaced by Vice President Mike Pence.
The Association of American Physicians and Surgeons (AAPS) is a politically conservative non-profit association that promotes medical misinformation,such as HIV/AIDS denialism,the abortion-breast cancer hypothesis,vaccine and autism connections,and homosexuality reducing life expectancy. The association was founded in 1943 to oppose a government attempt to nationalize health care. The group has included notable members,including American Republican politicians Ron Paul,Rand Paul and Tom Price.
Regeneron Pharmaceuticals,Inc. is an American biotechnology company headquartered in Westchester County,New York. The company was founded in 1988. Originally focused on neurotrophic factors and their regenerative capabilities,giving rise to its name,the company then branched out into the study of both cytokine and tyrosine kinase receptors.
Eric Jeffrey Topol is an American cardiologist,scientist,and author. He is the founder and director of the Scripps Research Translational Institute,a professor of Molecular Medicine at The Scripps Research Institute,and a senior consultant at the Division of Cardiovascular Diseases at Scripps Clinic in La Jolla,California. He is editor-in-chief of Medscape and theheart.org. He has published three bestseller books on the future of medicine:The Creative Destruction of Medicine (2010),The Patient Will See You Now (2015),and Deep Medicine:How Artificial Intelligence Can Make Healthcare Human Again (2019). He was also commissioned by the UK 2018–2019 to lead planning for the National Health Service's future workforce,integrating genomics,digital medicine,and artificial intelligence.
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food,Drug,and Cosmetic Act as added to and amended by various Acts of Congress,including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA),as codified by 21 U.S.C. § 360bbb-3,to allow the use of a drug prior to approval. It does not constitute approval of the drug in the full statutory meaning of the term,but instead authorizes the FDA to facilitate availability of an unapproved product,or an unapproved use of an approved product,during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.
Brett P. Giroir is an American pediatrician and a former four-star admiral in the U.S. Public Health Service Commissioned Corps. He currently serves on the board of directors for Remote Area Medical,and as the chief medical advisor for Gauss Surgical. He previously served as the 16th assistant secretary for health during the Trump administration from February 15,2018,to January 19,2021. He concurrently served as the secretary's principal public health and science adviser,the senior adviser for the Health Resources and Services Administration,the Centers for Disease Control and Prevention,and the Substance Abuse and Mental Health Services Administration as well as the senior adviser to the secretary for Opioid Policy. From 2020 to 2021,he served additionally as the director of the U.S. coronavirus diagnostic testing,and as the U.S. representative on the World Health Organization Executive Board. As COVID-19 testing czar,he was part of the White House Coronavirus Task Force.
Scott Gottlieb is an American physician and investor who served as the 23rd commissioner of the Food and Drug Administration (FDA) from 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,a member of the board of directors of Illumina,Inc.,a contributor to the cable financial news network CNBC,and a frequent guest on 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.
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Misinformation related to the COVID-19 pandemic has been propagated by various public figures,including officials of the United States government. The Trump administration in particular made a large number of misleading statements about the pandemic. A Cornell University study found that former U.S. President Donald Trump was "likely the largest driver" of the COVID-19 misinformation infodemic in English-language media,downplaying the virus and promoting unapproved drugs. Others have also been accused of spreading misinformation,including U.S. Secretary of State Mike Pompeo,backing conspiracy theories regarding the origin of the virus,U.S. senators and New York City mayor Bill de Blasio,who downplayed the virus.
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