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• W4386584304 abstract "Figure: FDA Commissioner Stephen Hahn, MD, at a White House press briefing April 24, 2020.Figure‘The White House can overrule any attempts by the FDA to toughen guidelines for a coronavirus vaccine.”—President Trump (CNN. Sept. 24, 2020; http://cnn.it/3oCDsWk.) “Science will guide our decisions; FDA will not permit any pressure from anybody to change that.”—Stephen Hahn, MD, FDA Commissioner (FDA. Sept. 29, 2020; http://bit.ly/35ywjyJ.) “Dear Commissioner Hahn: Tell the Truth or Resign.”—Eric Topol, MD, Gary & Mary West Endowed Chair of Innovative Medicine, the Executive Vice President, and a Professor of Molecular Medicine, Scripps Research, and the Director and Founder of the Scripps Research Translational Institute (Medscape. Aug. 31, 2020; http://wb.md/3oECZ5X.) Dr. Hahn is a radiation oncologist who was a researcher and later the chief medical executive at MD Anderson Cancer Center. He was appointed FDA Commissioner to replace Scott Gottlieb, MD, in December 2019, and became a part of Vice President Mike Pence's White House Coronavirus Task Force on March 1, 2020. Timeline of Disintegration March 2020: President Trump promoted hydroxychloroquine as a miracle cure. (U.S. News & World Report. March 31, 2020; http://bit.ly/38Ba9O1.) Dr. Hahn issued an Emergency Use Authorization (EUA) for hydroxychloroquine without any meaningful supporting evidence. (FDA. March 28, 2020; https://bit.ly/3sfRrn4.) April 2020: Rick Bright, PhD, a whistleblower and the former director of the Biomedical Advanced Research and Development Authority, reported that Dr. Hahn instructed FEMA Administrator Peter Gaynor to distribute hydroxychloroquine to pharmacies nationwide even though the EUA issued by the FDA did not approve hydroxychloroquine for outpatient COVID-19 use. (NPR. May 5, 2020; http://n.pr/2N1BeSx.) May 2020: Remdesivir was given EUA status with a limited press release. Scientific details were not released to the public for another three weeks. The data have weak correlation data with no mortality benefit. (FDA. May 1, 2020; http://bit.ly/35A4eXQ.) June 2020: The multiple deaths of COVID-19 patients linked to hydroxychloroquine led the FDA to revoke the EAU it had previously instituted. (FDA. June 15, 2020; http://bit.ly/3qesoyZ.) July 2020: President Trump stated that 99 percent of coronavirus cases are totally harmless. (Washington Post. July 8, 2020; http://wapo.st/3bKynrt.) Dr. Hahn was interviewed and asked if he supported the President's claim. He responded, “I'm not going to get into who is right and who is wrong.” (Washington Post. July 5, 2020; http://wapo.st/39lGXtI.) August 2020: President Trump referred to convalescent plasma as a “very historic breakthrough.” (White House. Aug. 23, 2020; http://bit.ly/38CFekv.) Health and Human Services Secretary Alex Azar said in a press conference that convalescent plasma was “a major advance,” and Dr. Hahn followed that by saying that “a 35 percent improvement in survival is a pretty substantial clinical benefit,” and that 35 of 100 sick with COVID-19 would be saved because of the admission of plasma. (Washington Post. Aug. 25, 2020; http://wapo.st/3bwsgXk.) President Trump accused a “deep state” at the FDA of blocking authorization. (Reuters. Aug. 23, 2020; http://reut.rs/3oCzCfS.) The delay was that the NIH was concerned that the effectiveness of treatment had not been demonstrated by research. (NIH. Sept. 22, 2020; http://bit.ly/39uoYRO.) The Fallout This disintegration of scientific integrity at the FDA is not simply a fallout of unique political pressures of the coronavirus. The FDA fundamentally changed the process by which a drug applying for FDA approval is reviewed in June 2019. Separate reviews by separate teams focusing on areas of expertise such as clinical pharmacology, toxicology, and biostatistics, to name a few, were now integrated into one summary report. This makes the review less diverse and less detailed and therefore the data and criticism less accessible. This review has always been confidential and can only have full disclosure if one submits a Freedom of Information Act, and that often takes years to process (think of Tamiflu by Roche and the years it took the Cochrane Review to acquire the FDA's unpublished data and prove its ineffectiveness—and that still required litigation). Criticism Eric Topol, MD, responded to Dr. Hahn's statements about convalescent plasma by saying, “Your statement was based on a preprint, which by definition has not been peer-reviewed.... It is a retrospective, observational study of over 35,000 patients who received convalescent plasma, without any controls or any untreated patients for comparison. ... The claim of reduction of mortality is totally unsubstantiated. That was based on improved survival in a subgroup of a subgroup of a subgroup from about 1000 patients. ... [T]his is illegitimate analysis that, at best, is hypothesis-generating.” (Medscape. Aug. 31, 2020; http://wb.md/3oECZ5X.) Dr. Hahn responded on Twitter: “I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. 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.” (Aug. 24, 2020; https://bit.ly/2N0611V.) Transparency and Integrity The FDA under Dr. Hahn has repeatedly approved drugs under emergency use authorization, including hydroxychloroquine, remdesivir, and convalescent plasma. These were approved with no published scientific data for the scientific community to review. And when publications were made available, they were grossly overpromoted or given false conclusions for someone who should know better, seeing that he has spent his career in research. The most concerning pieces to this story are not the inexplicable decisions by Dr. Hahn as much as the lack of integrity not to push back against a President who needed these “miracle” drugs to form a narrative of his administration directing scientific success during this pandemic. Our most powerful and trusted agency, not only for medications and devices but for vaccinations, is failing to bolster its foundations of transparency, accountability, integrity, and technical and scientific proficiency." @default.
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