August 24, 2020

In a controversial move, FDA authorizes emergency use of blood plasma for Covid-19

Daily Briefing

    FDA on Sunday issued an emergency use authorization (EUA) that allows providers to use convalescent plasma to treat patients hospitalized with Covid-19, sparking mixed reactions from public health experts—some of whom have expressed concerns that there isn't yet enough data showing the experimental treatment is effective.

    How Covid-19 is changing the future of the health care industry

    US new coronavirus cases surpass 5.7M, deaths top 176K

    The move comes as U.S. officials as of Monday morning reported a total of 5,713,700 cases of the novel coronavirus since the country's epidemic began—up from 5,262,700 cases reported as of the morning of Aug. 14.

    Data from the New York Times shows that Guam, the U.S. Virgin Islands, and nine states—Hawaii, Illinois, Iowa, Kansas, Maine, North Dakota, South Dakota, Vermont, and Wyoming—saw their average daily numbers of newly reported coronavirus cases rise over the past 14 days.

    The Times' data also shows that the average daily numbers of newly reported coronavirus cases over the past two weeks remained mostly stable in Puerto Rico and 17 states: Alaska, California, Connecticut, Indiana, Kentucky, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, and Rhode Island.

    In addition, the Times' data shows that Washington, D.C., and 24 states saw their average daily numbers of newly confirmed coronavirus cases decrease over the past 14 days: Alabama, Arizona, Arkansas, Colorado, Delaware, Florida, Georgia, Idaho, Louisiana, Maryland, Massachusetts, Nevada, New Hampshire, New Mexico, Ohio, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wisconsin.

    U.S. officials as of Monday morning also reported a total of 176,694 deaths linked to the novel coronavirus since the country's epidemic began—up from 167,165 deaths reported as of the morning of Aug. 14.

    According to the Times' data, 12 states saw their average daily numbers of newly reported deaths linked to the coronavirus rise over the past 14 days: Georgia, Hawaii, Indiana, Iowa, Kansas, Kentucky, Minnesota, North Dakota, Oklahoma, Oregon, Tennessee, and Wyoming.

    The coronavirus is now the third-leading cause of death in the United States, behind heart disease and cancer, according to analyses of recent CDC data. The data includes tallies of heart disease and cancer deaths that occurred in the United States in 2018, the most recent year for which CDC has released such data. Bloomberg reports that "there's typically little change from year to year" in those tallies. As such, if the numbers of heart disease and cancer deaths that occurred in the United States in 2018 hold relatively steady for 2020, the coronavirus would be the third-highest cause of death in the country this year so far.

    CDC projects that the number of deaths linked to the coronavirus in the United States will continue to increase, with the country likely seeing up to 200,000 coronavirus-related deaths by Labor Day.

    FDA issues EUA for convalescent plasma to treat hospitalized Covid-19 patients

    As the coronavirus continues to spread throughout the country, FDA on Sunday issued an EUA allowing wider use of convalescent plasma to treat patients hospitalized with Covid-19, the disease caused by the virus.

    FDA issued the EUA just days after a group of leading federal health officials—including NIH Director Francis Collins and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseasesstepped in to halt the authorization, the New York Times reports. Senior Trump administration officials last week told the Times that the group of top health officials urged FDA to delay the EUA because existing data on convalescent plasma as a potential treatment for Covid-19 has not yet shown whether it's effective.

    According to the Times, FDA had drafted an EUA for the experimental treatment after a clinical trial sponsored by NIH and conducted by the Mayo Clinic, which involved more than 35,000 patients, suggested that treating patients with severe cases of Covid-19 using recovered coronavirus patients' blood plasma was associated with lower mortality rates. The trial did not have a control group, however, making it hard for researchers to discern whether the experimental treatment caused the lower death rates.

    But after news broke of the EUA's delay, President Trump last week told reporters that he believed FDA was moving slowly on granting the EUA for blood plasma as an experimental Covid-19 treatment due to political reasons. In addition, Trump in a tweet posted Saturday wrote, "The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the [coronavirus] vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd."

    In a release announcing the EUA, FDA said it had determined that, based on current evidence, "it is reasonable to believe that Covid-19 convalescent plasma may be effective in lessening the severity or shortening the length of Covid-19 illness in some hospitalized patients."

    An FDA official in an accompanying clinical memorandum cited clinical evidence suggesting that convalescent plasma may be an effective treatment for Covid-19 and that benefits of the experimental therapy outweigh the treatment's known risks. The official in the memo stated that existing data "support[s] the conclusion that [convalescent plasma] to treat hospitalized patients with Covid-19 meets the 'may be effective' criteria for issuance of an EUA." However, the official added, "Adequate and well-controlled randomized trials remain nonetheless necessary for a definitive demonstration of … efficacy and to determine the optimal product attributes and the appropriate patient populations for its use."

    FDA said the EUA "is not intended to replace randomized clinical trials" on the experimental treatment, and the agency noted that "facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of Covid-19 convalescent plasma."

    Separately, Trump during a White House press conference on Sunday said the EUA "will dramatically expand access to" convalescent plasma for use to treat qualifying Covid-19 patients.

    However, STAT News reports that it is unclear whether the EUA will increase access to convalescent plasma as a Covid-19 treatment in practice, as providers already have used the experimental therapy to treat tens of thousands of qualifying patients under FDA's expanded access program. Further, there are limited supplies of plasma donated by patients who have recovered from coronavirus infection, meaning there's limited access to the potential treatment, according to STAT News.

    EUA garners mixed reviews

    FDA's decision to issue the EUA despite the imperfect evidence on whether blood plasma is an effective treatment for Covid-19 drew mixed reviews.

    For instance, former FDA Commissioner Scott Gottlieb in a tweet posted Sunday wrote, "Plasma is probably incrementally helpful to Covid patients and meets criteria for an EUA. We need to keep FDA decisions with FDA. The FDA professional staff supported this. It's their decision."

    But Eric Topol, founder and director of the Scripps Research Translational Institute, in a tweet posted Sunday wrote, "There's no evidence to support any survival benefit" among Covid-19 patients who were treated with the experimental therapy under the trial conducted by NIH and the Mayo Clinic, "[Two] days ago FDA's website stated there was no evidence for an EUA," he added.

    And Rachel Sachs, an associate professor of law at Washington University in St. Louis, in a tweet wrote that, because of the political pressure facing FDA, issuing the EUA without evidence from a randomized clinical trial "risks further damage to public trust in the agency."

    Trump admin reportedly eyeing fast-tracked FDA authorization for coronavirus vaccine

    Separately, some news outlets have reported that Trump, White House Chief of Staff Mark Meadows, and Department of the Treasury Secretary Steven Mnuchin have discussed with FDA officials the possibility of fast-tracking an EUA for a coronavirus vaccine candidate developed and being tested in late-stage trials by AstraZeneca in partnership with Oxford University, FierceBiotech reports. According to CNBC, three people familiar with the discussions reportedly told the Financial Times that the Trump administration is hoping to have FDA authorize a vaccine before the upcoming presidential election.

    However, AstraZeneca reportedly told the Financial Times that it hasn't had contact with U.S. officials regarding a potential EUA for the vaccine candidate, and a spokesperson for HHS told the Financial Times that any claims regarding federal officials' discussions with FDA about issuing an EUA for a coronavirus vaccine before November's presidential election are "absolutely false."

    According to CNBC, the White House did not immediately respond to a request for comment on the matter. Further, FierceBiotech reports that FDA Commissioner Stephen Hahn in recent months has said FDA will not authorize use of a coronavirus vaccine unless evidence on its effectiveness and safety is thoroughly vetted by the agency (Armstrong, Bloomberg, 8/21; Mascarenhas, CNN, 8/17; Guzman, "Changing America," The Hill, 8/14; Florko, STAT News, 8/23; Ayesh, Axios, 8/23; LaFraniere, New York Times, 8/24; Burton, Wall Street Journal, 8/23; Brennan, Politico, 8/23; FDA release, 8/23; New York Times, 8/24; Taylor, FierceBiotech, 8/24; Macias, CNBC, 8/23).

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