Dozens of major U.S. hospitals have been embroiled in controversy over whether to ignore a federal decision to allow the use of a comprehensive blood plasma crisis from recovered COVID patients to treat their disease in favor of devoting their resources to gold-standard clinical trials. For good.
As many as 45 hospitals from the coast to the coast showed interest in collaborating for a randomized, controlled clinical trial, sponsored by the Nderbilt University Medical Center, said Chief Investigator Dr. Said Todd Rice.
Officials at some hospitals said they were only considering committing to a clinical trial – and were avoiding or reducing potential plasma use by the Federal Food and Drug Administration on Aug. 23 by emergency use authorities.
The response comes amid concerns that the Trump administration has pressured the FDA to allow the widespread use of convulsive plasma, which has already been administered to more than 77,000 Kovid patients under US President Donald Trump. Scientists called for more evidence that covid plasma is beneficial.
Reacting to the FDA’s decision this week, national health panel organizations said the treatment “should not be considered a standard of care for the treatment of COVID-19 patients” and that well-designed trials are needed to determine whether there is a cure. Helpful data yet suggest that treatment may be beneficial, but it is not conclusive.
“It’s an important scientific question that we don’t have the answer to yet,” said Rice, an associate professor of medicine and director of VUMC’s medical intensive care unit.
Convalescent plasma uses antibody-rich blood products that people have recovered from a viral infection and introduces it to sufferers in the hope that treatment will increase their ability to fight the virus. The approach has been used experimentally for more than a century to fight other viral diseases, including the 1918 flu, measles, Ebola, SARS and H1N1 influenza.
Last month, NIH officials awarded a અધ 34 million study of rice, the Passive Immunity Trial to the Nation for the Nation for a COW Weed-19, dubbed Passit Oniii, which is also funded by the country’s music superstar Dolly Parton. The trial, which aims to register 1000 adult hospitalized patients, could meet its targets by the end of October. Rice said she could make immediate changes to clinical practice if she showed evidence of potential benefits for covid patients, Rice said.
Rice said half of the participants will receive high levels of convulsant plasma with antibodies fighting the disease from the staples of more than 150 units of the product already collected. In the second part a placebo solution will be obtained.
Although hearings began in April, registration has been slow. The fund allows registration at more than 50 sites across the country. This sparks new conversations about joining the hearing – and about not employing the disputed authorization issued by the FDA, said Dr. John H. Snyder, director of the blood bank laboratory at the University of Minnesota Medical School. Said Claudia Cohen. She expects her organization to make a decision this week.
“I’d rather frame the FDA for a rejection, but because of the long-term idea,” said Cohen, who is also the medical director of AABB, an international nonprofit focused on bleeding medicine and cellular therapy.
Officials at Ohio State University Wexner Medical Center have chosen to join the trial and are considering making it a “first option” for qualified COVID patients, said Dr. Sonal Pannu, an assistant professor and pulmonologist.
“Many academic leaders believe we should conduct a trial, and seriously limit emergency use authorization or EUA,” he said, adding that first patients could be registered soon. Plasma can still be used to treat patients such as prisoners under the EU who are unable to agree to join clinical trials, he added.
The University of Washington and Washington University have taken a similar approach, said Dr. A.S., an assistant professor of emergency medicine who led the trial at the Seattle site. Said Nicholas Johnson. “We are really interested in registering patients as a first option,” he said.
The questions are the same as those raised with hydroxychloroquine, Trump argued for the treatment of COVID-19. FDA officials issued the EUA for the drug in April, only to revoke it in June after data showed it could be harmful.
“On some occasions, we have allowed clinical practice to go beyond science,” Jones said. “We’ve learned that lesson many times now.”
FDA officials did not respond to requests for comment.
The director of NIH, Dr. Dr. Francis Collins and the nation’s leading infectious disease doctor. Top federal health leaders, including Anthony Fawcett, initially resisted the EU’s move to provide conventional plasma last month, the New York Times said. Very weak.
Trump has criticized the FDA for moving too slowly to speed up COVID-19 treatment and approval of vaccines. He announced the EUA on the eve of the Republican National Convention, calling it a “truly historic declaration.”
Arthur Caplan, a professor of bioethics at New York University School of Medicine, said the issuance of the EUA puts the fate of clinical trials in “extreme peril”. With convincing plasma in a very short supply, it sets the stage for a fight over access access and makes sick patients less inclined to join the trial, where they can get a placebo.
“If you have the EU, it starts to hurt the trials,” Capla said.
Although the FDA has authorized convalescent plasma for sick patients with COVID-19, hospitals that are on trial or refuse to supply it out of trial are sure to face questions from families.
Cohen said it “creates a very interesting and delicate ethics problem.”
“If you are only committed to a randomized controlled trial, you are committed to a long-term dedication to science.” “The question is, is it morally inappropriate not to provide a treatment that is likely to be beneficial?”
“Once the need for strict scientific results is understood, most patients are willing to participate in clinical trials – even eager,” said Johnson of Washington University in Washington.
And biotheist Capla praised the hospitals’ decision to reduce the EU and focus on trials, calling it “a beautiful woman’s action.”
“It makes sense,” he said. The answer to the question “Does plasma do anything?” Is likely to produce an answer.
