A doctor holds a bag of blood plasma donated by a COVID-19 survivor at at blood bank in La Paz, Bolivia, in June.
A doctor holds a bag of blood plasma donated by a COVID-19 survivor at at blood bank in La Paz, Bolivia, in June.
The U.S. Food and Drug Administration has reportedly put a hold on granting emergency authorization to use blood plasma as a treatment for the novel coronavirus, though the Mayo Clinic research study that Ballad Health is a part of wonât be affected.
According to the New York Times, the FDA was preparing to issue an emergency authorization for the treatment before a group of top health officials â including National Institutes for Health Director Dr. Francis Collins and Dr. Anthony Fauci, the nationâs top infectious disease expert â intervened, saying the results of the study werenât strong enough to justify emergency approval.
âThe three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,â H. Clifford Lane, clinical director at the National Institute of Allergy and Infectious Diseases, told the Times.
In a statement to the Press, a Mayo Clinic spokesperson said the program is not intended to be a clinical trial and they chose to share their data because they âobserved possible signals of efficacy.â
âThe data could advance the discussion about the efficacy of convalescent plasma treatment, and we acknowledge that additional scientific investigation is needed,â the statement read. âThe FDA has asked for additional data for review by their teams, and Mayo Clinic is providing that data. The discussion and simultaneous analyses continue. We welcome that further review.
âWe agree on the need for randomized clinical trials as a scientifically sound approach,â the statement continued. âWe believe the data from the EAP is significant and could be used to provide evidence to conduct RCTs going forward. We will always support bolstering the best science that will result in the most effective treatment for patients and welcome methodical scrutiny of our data.â
East Tennessee State Universityâs Infectious Diseases Division chief, Dr. Jonathan Moorman, said data from the convalescent plasma studies have not yet proven its efficacy, saying âitâs never really been tested in a randomized, placebo-controlled way as yet,â but that he thinks it will be.
âI think thereâs multiple small studies out there that look like it could be effective, but none of them are really placebo-controlled,â Moorman said, later noting that some of the data out of the Mayo (Clinic) study suggests some effect, but itâs not an overwhelmingly convincing study as yet to show that it actually works. âI have optimism about it, you know with one good clinical trial we can answer the question, but I donât think the answer is really out there yet.â
The treatment uses blood plasma donated by people who have recovered from COVID-19, which is then given to patients.
with the hope that the antibodies in the plasma will help patients fight off the virus, and keep those who arenât severely ill from reaching that point. According to the most recent data published from the Mayo Clinicâs study, more than 35,000 patients â 52.3% of whom were in intensive care â received the treatment as part of an expanded access program designed to âexplore the potential signals of efficacyâ of the treatment.
The data suggested that the treatment was most effective when given within three days of diagnosis and when the plasma had a higher amount of antibodies. After one week, those who were given the plasma within three days had a mortality rate of 8.7%, compared to 11.9% in those who received it later. After a month, those numbers jumped to 21.6% compared to 26.7%.
Back in April, Ballad Health announced it would be taking part in the Mayo Clinicâs âgame-changerâ study, with the systemâs Chief Clinical Officer Amit Vashist calling it a âvery exciting developmentâ at the time. As of Friday, Ballad Health has treated 260 patients with donated plasma, and had seen its donations triple in a matter of weeks. During a press conference on Aug. 12, Balladâs Chief Physician Executive, Dr. Clay Runnels, called the increase in donations âreally impressiveâ and expressed promise in the treatment while cautioning that they donât know how effective it is yet.
âWe canât say exactly, accurately, how effective convalescent plasma is until the national study that weâre a part of â the data is published,â Runnels said. âI can tell you, anecdotally, physicians donât generally order things that they donât think work, and so the growth of the use tells you a little bit automatically about how effective they and the patients are finding it.â
Runnels later added that itâs possible that anecdotal evidence isnât accurate, âbut what weâre seeing anecdotally right now is a pretty significant impact from our perspective and, more important, the prospective of the patients and the treating physicians.â
Called a possible âgame-changerâ by system leaders, Ballad Health will participate in a national study for a novel coronavirus (COVID-19) treatment.
Jonathan Roberts is a journalist and photographer with a love for iced tea and traveling. A graduate of East Tennessee State University, Jonathan has been with the Press since 2019 and is a member of the National Association of Hispanic Journalists.
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Source: https://www.johnsoncitypress.com/living/health-care/ballads-role-in-blood-plasma-covid-19-study-unaffected-by-fda-ruling/article_871829c6-e2fb-11ea-a42e-8b001bde8015.html
World news – US – Ballad’s role in blood plasma COVID-19 study unaffected by FDA ruling