Hospitals Set to Defy FDA’s COVID Plasma Directive
Thursday, September 3, 2020 (Kaiser News) – Dozens of major hospitals across the United States are grappling with whether to ignore a federal decision allowing broader emergency use of blood plasma from recovered COVID patients to treat the disease in favor of devoting their resources to a benchmark clinical trial that could help establish the science in earnest.
As many as 45 hospitals from coast to coast have expressed interest in collaborating on a controlled, randomized clinical trial sponsored by Vanderbilt University Medical Center, said lead researcher Dr Todd Rice.
Officials at some hospitals have said they plan to embark only on the clinical trial – and to avoid or minimize the use of convalescent plasma thanks to an emergency use authorization issued on August 23. by the Federal Food and Drug Administration.
The response comes as the Trump administration has pressured the FDA to approve wider use of convalescent plasma, which has already been administered to more than 77,000 COVID patients in the United States. President Donald Trump has called the treatment a “potent therapy” even as government scientists have called for more evidence that COVID plasma is beneficial.
A National Institutes of Health panel this week challenged the FDA’s ruling, saying the therapy “should not be considered the standard of care for treating patients with COVID-19” and that well-designed trials are needed to determine if therapy is helpful. Data so far suggests that the treatment could be beneficial, but it is not definitive.
“This is an important scientific question that we do not yet have an answer to,” said Rice, associate professor of medicine and director of the VUMC’s medical intensive care unit.
Convalescent plasma uses an antibody-rich blood product taken from people who have recovered from a viral infection and injects it into people who are still suffering in the hope that the therapy will revive their immune systems, increasing their ability to fight off the virus. The approach has been used on an experimental basis for over a century to combat other virulent diseases, including the 1918 flu, measles, Ebola virus, SARS, and H1N1 influenza.
NIH officials last month awarded $ 34 million to Rice’s study, the nation’s passive immunity trial for COVID-19, dubbed PassItOnII, which also received funding from the music superstar country Dolly Parton. The trial, which aims to recruit 1,000 hospitalized adult patients, could reach its goals by the end of October. If it shows evidence of likely benefit for COVID patients, it could immediately change clinical practice, Rice said.
Half of the participants will receive convalescent plasma with high levels of anti-disease antibodies from a stock of more than 150 units of the product already collected, Rice said. The other half will receive a placebo solution.
Although the trial was launched in April, registration has been slow. The funding enables enrollment at more than 50 sites across the country. This sparked new conversations about taking part in the trial – and not using the controversial FDA clearance, said Dr Claudia Cohn, director of the blood bank laboratory at the Faculty of medicine from the University of Minnesota. She expected her institution to decide this week.
“I prefer to present it as not rejecting the FDA, but simply as a longer-term view,” said Cohn, who is also the medical director of AABB, an international nonprofit focused on transfusion medicine and cell therapies.
At Ohio State University’s Wexner Medical Center, officials have chosen to participate in the trial and are considering making it “the first option” for qualifying COVID patients, said the Dr Sonal Pannu, assistant professor and pulmonologist.
“A lot of university leaders think we should give it a try, and we would severely limit” the emergency use authorization, or EUA, she said, noting that the first patients could be recruited soon. The plasma could still be used under the EUA to treat patients such as prisoners, who cannot consent to participate in a clinical trial, she added.
It’s the same position taken by the University of Washington, said Dr. Nicholas Johnson, assistant professor of emergency medicine who is leading the trial at the Seattle site. “We are really interested in enrolling patients as the first option,” he said.
The questions are similar to those raised with hydroxychloroquine, another treatment Trump has touted for the treatment of COVID-19. FDA officials issued an EUA for the drug in April, only to revoke it in June after data indicated the drug could be harmful.
“There are a few times where we have put clinical practice ahead of science,” Johnson said. “We have learned this lesson many times now.”
FDA officials did not respond to requests for comment.
Top federal health leaders, including NIH Director Dr Francis Collins and Dr Anthony Fauci, the country’s leading infectious disease physician, initially resisted the decision to issue the EUA for plasma from convalescent last month, telling The New York Times the evidence was too weak.
Trump has criticized the FDA for moving too slowly to speed up approval of COVID-19 treatments and vaccines. He announced the EUA on the eve of the Republican National Convention, calling it a “truly historic announcement.”
The issuance of the EUA puts the fate of clinical trials in “extreme danger,” said Arthur Caplan, professor of bioethics at the New York University School of Medicine. With very low amounts of convalescent plasma, it paves the way for struggles for access and makes sick patients less likely to participate in a trial, where they could be given a placebo.
“If you have the EUA, it starts to damage the trials,” Caplan said.
Still, since the FDA has cleared convalescent plasma for patients with COVID-19, hospitals that are hesitant or unwilling to provide it outside of a trial are sure to answer families’ questions.
This creates “a very interesting and delicate ethical problem,” Cohn said.
“If you are only committing to the randomized controlled trial, you are committing to long-term dedication to science,” she said. “The question is, is it ethically inappropriate not to provide therapy that has been shown to be potentially beneficial?”
Johnson, of the University of Washington, said most patients were willing – even willing – to participate in clinical trials once they understood the need for rigorous scientific results.
And Caplan, the bioethicist, applauded the hospitals’ decision to downplay the EUA and focus on the trial, calling it “pretty fiery action.”
“It’s reasonable,” he says. “It is likely to really generate an answer to the question ‘Is COVID convalescent plasma doing anything? “”
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