Uncontrolled spread, p.51
Uncontrolled Spread, page 51
25.Heesu Lee, “These Elite Contact Tracers Show the World How to Beat Covid-19,” Bloomberg, July 25, 2020.
26.Gregg A. Brazinsky, “South Korea Is Winning the Fight Against Covid-19. The U.S. Is Failing.,” Washington Post, April 10, 2020.
27.Slavitt, Preventable: The Inside Story of How Leadership Failures, Politics, and Selfishness Doomed the U.S. Coronavirus Response, page 28.
28.Choe Sang-Hun, “South Korean Leader Said Coronavirus Would ‘Disappear.’ It Was a Costly Error.,” New York Times, March 2, 2020.
29.Andrea Crisanti and Antonio Cassone, “In One Italian Town, We Showed Mass Testing Could Eradicate the Coronavirus,” Guardian, March 20, 2020.
30.Franco Ordonez, “Ex-Officials Call For $46 Billion for Tracing, Isolating in Next Coronavirus Package,” National Public Radio, April 27, 2020.
31.CNBC, “Gottlieb, AEI’s Michael Strain: Congress Should Support Cities Amid Coronavirus Outbreak,” March 12, 2020.
32.Scott Gottlieb (@ScottGottliebMD), “THREAD: In U.S. we face two alternative but hard outlooks with #COVID19: that we follow a path similar to South Korea or one closer to Italy. We probably lost chance to have an outcome like South Korea. We must do everything to avert the tragic suffering being borne by Italy 1/10,” Twitter, March 12, 2020, 7:03 a.m.
33.Ibid.
34.Laurie McGinley, “FDA, Industry Step Up Efforts to Avert Drug Shortages after Puerto Rico Hurricane,” Washington Post, September 29, 2017; and Katie Thomas and Sheila Kaplan, “Hurricane Damage in Puerto Rico Leads to Fears of Drug Shortages Nationwide,” New York Times, October 4, 2017.
35.US Department of Homeland Security, “Implementing 9/11 Commission Recommendations: Progress Report 2011,” 2011, https://www.dhs.gov/xlibrary/assets/implementing-9-11-commission-report-progress-2011.pdf.
36.Vijay Singh et al., “Radiation Countermeasure Agents: An Update (2011–2014),” Expert Opinion on Therapeutic Patents 24, no. 11 (2014): 1229–55; and Vijay Singh et al., “Medical Countermeasures for Unwanted CBRN Exposures: Part II Radiological and Nuclear Threats with Review of Recent Countermeasure Patents,” Expert Opinion on Therapeutic Patents 26, no. 12 (2016): 1399–1408.
37.US Food and Drug Administration, “FDA Approves Radiation Medical Countermeasure,” April 30, 2019, https://www.fda.gov/emergency-preparedness-and-response/about-mcmi/fda-approves-radiation-medical-countermeasure.
38.US Department of Health and Human Services, “HHS Boosts Stockpile of Products to Treat Acute Radiation Syndrome,” September 26, 2013, https://www.emsworld.com/news/11178384/hhs-boosts-stockpile-products-treat-acute-radiation-syndrome.
39.Katie Thomas and Knvul Sheikh, “Estimates Fall Short of F.D.A.’s Pledge for 1 Million Coronavirus Tests,” New York Times, March 3, 2020.
40.Ali S. Khan, “Public Health Preparedness and Response in the USA Since 9/11: A National Health Security Imperative,” Lancet 378, no. 9794 (2011): 953–6.
41.Due to the temporal nature of Zika virus RNA in blood and urine samples, a negative blood test for the infection’s genetic material (using PCR) doesn’t mean that a person isn’t infected. The levels of virus in the blood can wax and wane and impact the ability to detect its RNA through the kinds of tests used to screen for COVID. As a consequence, to test for infections like Zika, providers often also want to use serum tests that screen for the antibodies that the body produces in response to infection. See US Centers for Disease Control and Prevention, “Testing for Zika Virus Infections,” June 13, 2019, https://www.cdc.gov/zika/laboratories/types-of-tests.html.
42.US Centers for Disease Control and Prevention, “Technology Transfer: Frequently Asked Questions,” October 11, 2017, https://www.cdc.gov/os/technology/techtransfer/faq.htm.
43.“Researchers from Chiron Corp. and the Centers for Disease Control and Prevention (CDC) finally unmasked the insidious agent in 1988. The next year, they jointly published papers in Science describing the new virus and a way to test for it in blood samples.” See Jon Cohen, “The Scientific Challenge of Hepatitis C,” Science 285, no. 5424 (1999): 26–30; and Bradley v. Chiron Corp., 136 F.3d 1317 (Fed. Cir. 1998).
44.V. Slind-Flor, “Chiron Challenged on Hepatitis-C Patent,” Science 267, no. 5194 (1995): 23.
45.Ibid.
46.Paul Elias, “Feds Review Complaints That Chiron Hinders HCV Research,” Associated Press, February 28, 2004.
47.Sarah Karlin-Smith (@SarahKarlin), “This slide from @BARDA Acting Director Gary Disbrow is a good visual of US prioritizing funding for COVID-19 vaccines versus therapeutics,” Twitter, October 27, 2020, 10:18 a.m.
48.US Government Accountability Office, “Zika Supplemental Funding: Status of HHS Agencies’ Obligations, Disbursements, and the Activities Funded,” May 2018, https://www.gao.gov/assets/gao-18-389.pdf.
Chapter 15: Evidence Is Hard to Collect in a Crisis
1.US Centers for Disease Control and Prevention, “CDC Telebriefing—Updates On Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Investigation In The United States,” May 17, 2014.
2.Stephanie R. Bialek et al., “First Confirmed Cases of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Infection in the United States, Updated Information on the Epidemiology of MERS-CoV Infection, and Guidance for the Public, Clinicians, and Public Health Authorities,” Morbidity and Mortality Weekly Report 63, no. 19 (2014): 431–6.
3.Florida Department of Health Communications, “Health Officials Confirm First MERS-CoV Case in Florida,” May 12, 2014, http://www.floridahealth.gov/diseases-and-conditions/mers/_documents/mers-cov-press-release.pdf.
4.Aisha M. Al-Osail and Marwan J. Al-Wazzah, “The History and Epidemiology of Middle East Respiratory Syndrome Corona Virus,” Multidisciplinary Respiratory Medicine 12, no. 20 (2017).
5.World Health Organization, “Middle East Respiratory Syndrome Coronavirus (MERS-CoV)—Saudi Arabia,” December 4, 2015, https://www.who.int/csr/don/4-december-2015-mers-saudi-arabia/en/.
6.Al-Osail and Al-Wazzah, “The History and Epidemiology of Middle East Respiratory Syndrome Corona Virus.”
7.“A Chronicle on the SARS Epidemic, Chinese Law & Government,” Chinese Law & Government 36, no. 4 (2003): 12–5.
8.Al-Osail and Al.Wazzah, “The History and Epidemiology of Middle East Respiratory Syndrome Corona Virus.”
9.Nicholas Wade, “Origin of Covid—Following the Clues,” Medium, May 3, 2021.
10.Stanley Plotkin and Susan Plotkin, “The Development of Vaccines: How the Past Led to the Future,” Nature Reviews Microbiology 9 (2011): 889–93.
11.Stephen S. Morse and Ann Schluederberg, “Emerging Viruses: The Evolution of Viruses and Viral Disease,” Journal of Infectious Diseases 162, no. 1 (1990).
12.Simon J. Anthony et al., “Global Patterns in Coronavirus Diversity,” Virus Evolution 3, no. 1 (2017).
13.Yi Fan et al., “Bat Coronaviruses in China,” Viruses 11, no. 3 (2019): 210.
14.McKay and Dvorak, “A Deadly Coronavirus Was Inevitable. Why Was No One Ready?”
15.World Health Organization, “Prioritizing Diseases for Research and Development in Emergency Contexts,” https://www.who.int/activities/prioritizing-diseases-for-research-and-development-in-emergency-contexts.
16.The UK and EU were added to its roster of international sponsors.
Clive Cookson and Tim Bradshaw, “Davos Launch for Coalition to Prevent Epidemics of Emerging Viruses,” Financial Times, January 18, 2017.
17.Jason Beaubien, “Ebola Never Went Away. But Now There’s a Drug to Treat It,” National Public Radio, October 20, 2020.
18.World Health Organization, “Prioritizing Diseases for Research and Development in Emergency Contexts,” https://www.who.int/activities/prioritizing-diseases-for-research-and-development-in-emergency-contexts.
19.Steve Usdin, “DARPA’s Gambles Might Have Created the Best Hopes for Stopping COVID-19,” BioCentury, March 19, 2020.
20.Meg Tirrell (@megtirrell), “Dr. Janet Woodcock, 34-year veteran of FDA, says 90% of the clinical trials run during the pandemic won’t yield actionable results that will change practice. Tune in for our discussion about why at 4:30pmET today—and send Qs w hashtag #HealthyReturns.,” Twitter, October 14, 2020, 3:47 p.m.
21.Congressional Research Service, “The Defense Production Act of 1950: History, Authorities, and Considerations for Congress,” March 20, 2020, https://fas.org/sgp/crs/natsec/R43767.pdf.
22.Andrew Jacobs, “Despite Claims, Trump Rarely Uses Wartime Law in Battle Against Covid,” New York Times January 20, 2021; and White House Office of Trade and Manufacturing Policy, “How President Trump Uses the Defense Production Act to Protect Americans from the China Virus,” August 2020, https://www.documentcloud.org/documents/7036228-OTMP-DPA-Report-FINAL-8-13-20.html#document/p4.
23.Jacqui Wise and Rebecca Coombes, “Covid-19: The Inside Story of the RECOVERY Trial,” British Medical Journal 370, no. 2670 (2020).
24.RECOVERY Collaborative Group, “Dexamethasone in Hospitalized Patients with Covid-19,” New England Journal of Medicine 384 (2021): 693–704.
25.Scott Gottlieb and Mark McClellan, “Rules for Clinical Trials in a Pandemic,” Wall Street Journal, June 21, 2020.
26.Ibid.
27.Nicholas J. DeVito, Michael Liu, and Jeffrey K Aronson, “COVID-19 Clinical Trials Report Card: Chloroquine and Hydroxychloroquine,” Oxford COVID-19 Centre for Evidence-Based Medicine, May 11, 2020.
28.US Food and Drug Administration, “Electronic Reading Room: COVID,” May 11, 2021, https://www.fda.gov/regulatory-information/freedom-information/electronic-reading-room; and Steve Usdin, “FDA Documents Shed Light on Chaotic COVID Decision-Making during Trump Administration,” Biocentury, May 14, 2021.
29.Tina Nguyen, “How a Chance Twitter Thread Launched Trump’s Favorite Coronavirus Drug,” Politico, April 7, 2020.
30.Kevin Roose and Matthew Rosenberg, “Touting Virus Cure, ‘Simple Country Doctor’ Becomes a Right-Wing Star,” New York Times, April 2; and Katherine Eban, “‘I’ll Send You the Contact’: Documents Expose FDA Commissioner’s Personal Interventions on Behalf of Trump’s Favorite Chloroquine Doctor,” Vanity Fair, May 27, 2020.
31.Wright, “The Plague Year.”
32.Katherine Eban, “’A Tsunami of Randoms’: How Trump’s COVID Chaos Drowned the FDA in Junk Science,” Vanity Fair, January 19, 2021.
33.Christopher Rowland, Debbie Cenziper, and Lisa Rein, “White House Sidestepped FDA to Distribute Hydroxychloroquine to Pharmacies, Documents Show. Trump Touted the Pills to Treat Covid-19,” Washington Post, October 31, 2020.
34.Office of the Assistant Secretary for Preparedness and Response, “HHS Accepts Donations of Medicine to Strategic National Stockpile as Possible Treatments for COVID-19 Patients,” March 29, 2020, https://www.hhs.gov/about/news/2020/03/29/hhs-accepts-donations-of-medicine-to-strategic-national-stockpile-as-possible-treatments-for-covid-19-patients.html.
35.Yasmeen Abutaleb, Laurie McGinley, and Josh Dawsey, “Oracle to Partner with Trump Administration to Collect Data on Unproven Drugs to Treat Covid-19,” Washington Post, March 24, 2020.
36.The Public Readiness and Emergency Preparedness (PREP) Act authorizes the secretary of the Department of Health and Human Services to issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims: of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases; threats and conditions determined by the secretary to constitute a present, or credible risk of a future public health emergency; and to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures. See US Department of Health and Human Services, “Public Readiness and Emergency Preparedness Act,” March 16, 2021, https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx
37.Rowland, Cenziper, and Rein, “White House Sidestepped FDA to Distribute Hydroxychloroquine to Pharmacies, Documents Show. Trump Touted the Pills to Treat Covid-19.”
38.US Food and Drug Administration, Center for Drug Evaluation and Research Office of Surveillance and Epidemiology, “Pharmacovigilance Memorandum: Hydroxychloroquine and Chloroquine,” May 19, 2020, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/OSE%20Review_Hydroxychloroquine-Cholorquine%20-%2019May2020_Redacted.pdf.
39.Rowland, Cenziper, and Rein, “White House Sidestepped FDA to Distribute Hydroxychloroquine to Pharmacies, Documents Show. Trump Touted the Pills to Treat Covid-19.”
40.FDA Commissioner Steve Hahn would write in a blog post on May 29, 2020: “Since the hydroxychloroquine product is FDA-approved for other uses with a prescription, the donation agreements also allowed for it to be distributed for clinical trials and to the commercial market for use in the outpatient setting, if appropriate.” See Stephen M. Hahn, “Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic,” May 29, 2020, https://www.fda.gov/news-events/fda-voices/bringing-cancer-doctors-perspective-fdas-response-covid-19-pandemic; and Rowland, Cenziper, and Rein, “White House Sidestepped FDA to Distribute Hydroxychloroquine to Pharmacies, Documents Show. Trump Touted the Pills to Treat Covid-19.”
41.US Food and Drug Administration, “Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine,” June 15, 2020, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and.
42.US Food and Drug Administration, Center for Drug Evaluation and Research Office of Surveillance and Epidemiology, “Pharmacovigilance Memorandum.”
43.Laurie McGinley, “Controversy Erupts over Plan to Let Pentagon Authorize Unapproved Drugs for Battlefield Use,” Washington Post, November 9, 2017.
44.Laurie McGinley and Mark Berman, “Justice Department Says FDA ‘Lacks Jurisdiction’ over Death-Penalty Drugs,” Washington Post, May 14, 2019.
45.Leon G. Smith et al., “Observational Study on 255 Mechanically Ventilated Covid Patients at the Beginning of the USA Pandemic,” medRxiv, May 31, 2021; and Harriet Alexander, “Was Trump Right About Hydroxychloroquine All Along? New Study Shows Drug Touted by Former President can Increase COVID Survival Rates by 200%,” Daily Mail, June 10, 2021.
46.US Food and Drug Administration, “FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative,” January 27, 2021, https://www.fda.gov/about-fda/reports/fda-covid-19-pandemic-recovery-and-preparedness-plan-prepp-initiative.
47.Levin, “Biden’s Pandemic-Policy Challenge.”
48.Richard Harris, “FDA’s Hahn Apologizes for Overselling Plasma’s Benefits as a COVID-19 Treatment,” National Public Radio, August 25, 2020.
49.Steve Usdin, “FDA Documents Shed Light on Chaotic COVID Decision-making during Trump Administration,” Biocentury, May 14, 2021.
50.Marcus Banks, “NIH Halts Outpatient COVID-19 Convalescent Plasma Trial,” Scientist, March 4, 2021.
51.RECOVERY Collaborative Group, “Convalescent Plasma in Patients Admitted to Hospital with COVID-19 (RECOVERY): a Randomized Controlled, Open-Label Platform Trial,” Lancet (2021).
52.Katie Thomas and Noah Weiland, “The Covid-19 Plasma Boom Is Over. What Did We Learn From It?,” New York Times, April 17, 2021.
53.Matthew Perrone and Deb Reichmann, “FDA Chief Apologizes for Overstating Plasma Effect on Virus,” ABC News, August 25, 2020.
54.US Food and Drug Administration, Center for Biologics Evaluation and Research, “Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry,” January 2020, https://www.fda.gov/media/139638/download.
55.COVID Tracking Project, “The Long-Term Care COVID Tracker,” https://covidtracking.com/nursing-homes-long-term-care-facilities.
56.Ibid.
57.“Trump Administration Issues Call to Action Based on New Data Detailing COVID-19 Impacts on Medicare Beneficiaries,” US Centers for Medicare & Medicaid Services press release, June 22, 2020, https://www.cms.gov/newsroom/press-releases/trump-administration-issues-call-action-based-new-data-detailing-covid-19-impacts-medicare.
58.Denise Chow, “Coronavirus Missteps from CDC and FDA Worry Health Experts,” NBC News, August 31, 2021.
59.Matthew Herper and Nicholas Florko, “How Key Decisions Slowed FDA’s Review of a Covid-19 Vaccine—but also Gave It Important Data,” STAT, December 4, 2020.
Chapter 16: Getting Drugs to Patients
1.Maggie Haberman and Michael D. Shear, “Trump Says He’ll Begin ‘Quarantine Process’ After Hope Hicks Tests Positive for Coronavirus,” New York Times, October 1, 2020; and Luke Harding, “Hicks, Hubris and Not a Lot of Masks: The Week Trump Caught Covid,” Guardian, October 2, 2020.
2.Michael C. Bender and Rebecca Ballhaus, “Trump Didn’t Disclose First Positive Covid-19 Test While Awaiting a Second Test on Thursday,” Wall Street Journal, October 4, 2020.
3.Rev.com, “Donald Trump Sean Hannity Interview Transcript After Debate: Condemns White Supremacists, Talks Hope Hicks Testing Positive for COVID,” October 1, 2020.
4.Harriet Sinclair, “Trump Says He Is Scared of Germs and Needs to Drink from a Straw to Avoid Contamination,” Newsweek, September 26, 2017.
5.Jill Colvin and Zeke Miller, “Trump Says He and First Lady Tested Positive for Coronavirus,” Associated Press, October 1, 2020.
6.Noah Weiland et al., “Trump Was Sicker than Acknowledged with Covid-19,” New York Times, February 28, 2021.
7.US Food and Drug Administration, “Emergency IND Timeline,” February 20, 2018, https://www.fda.gov/drugs/investigational-new-drug-ind-application/emergency-ind-timeline.
8.Weiland et al., “Trump Was Sicker than Acknowledged with Covid-19.”
9.D. M. Weinreich et al., “REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19,” New England Journal of Medicine 384, no. 3 (2020): 238–51; and Peter Chen et al., “SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19,” New England Journal of Medicine 384, no. 3 (2020): 229–37.
