麻豆女优

Dozens of major hospitals across the U.S. 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 dedicating their resources to a gold-standard clinical trial that could help settle the science for good.

As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial sponsored by Vanderbilt University Medical Center, said principal investigator Dr. Todd Rice.

Officials at some hospitals said they are considering committing only to the clinical trial 鈥� and either avoiding or minimizing use of convalescent plasma through an emergency use authorization by the federal Food and Drug Administration.

The response comes amid concerns that the Trump administration pressured the FDA into approving broader use of convalescent plasma, which already has been administered to . President Donald Trump characterized the treatment as a 鈥減owerful therapy,鈥� even as government scientists called for more evidence that COVID plasma is beneficial.

A National Institutes of Health panel this week , saying that the therapy 鈥渟hould not be considered the standard of care for the treatment of patients with COVID-19鈥� and that well-designed trials are needed to determine whether the therapy is helpful. Data so far suggests the treatment could be beneficial, but it鈥檚 not definitive.

鈥淚t鈥檚 an important scientific question that we don鈥檛 have the answer to yet,鈥� said Rice, an associate professor of medicine and director of VUMC鈥檚 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 still suffering in the hopes that the therapy will jump-start their immune systems, boosting their ability to fight the virus. The approach has been used on an experimental basis for more than a century to fight other virulent diseases, including the 1918 flu, measles, Ebola, SARS and H1N1 influenza.

Last month, NIH officials awarded $34 million to Rice鈥檚 study, , dubbed PassItOnII, which has also received funding from country music superstar Dolly Parton. The trial, which aims to enroll 1,000 adult hospitalized patients, could meet its goals by the end of October. If it shows evidence of likely benefit to COVID patients, it could immediately change clinical practice, Rice said.

Half of the participants will receive convalescent plasma with high levels of disease-fighting antibodies from a stockpile of more than 150 units of the product already collected, Rice said. The other half will receive a placebo solution.

Though the trial launched in April, enrollment has been slow. The funding allows enlistment at more than 50 sites nationwide. That has spurred new conversations about joining the trial 鈥� and about not employing the controversial authorization issued by the FDA, said Dr. Claudia Cohn, director of the Blood Bank Laboratory at the University of Minnesota Medical School. She expected her institution to decide this week.

鈥淚鈥檇 rather frame it as not rejecting the FDA, but simply taking the longer view,鈥� said Cohn, who is also medical director for the AABB, an international nonprofit focused on transfusion medicine and cellular therapies.

At the Ohio State University Wexner Medical Center, officials have opted to join the trial and are considering making it 鈥渢he first option鈥� for COVID patients who qualify, said Dr. Sonal Pannu, an assistant professor and pulmonologist.

鈥淢any of the academic leaders believe we should do the trial, and we would be severely limiting鈥� the emergency use authorization, or EUA, she said, noting that first patients could be enrolled soon. The plasma still could be used under the EUA to treat patients such as prisoners, who are unable to consent to join a clinical trial, she added.

That鈥檚 the same stance adopted by the University of Washington, said Dr. Nicholas Johnson, an assistant professor of emergency medicine who鈥檚 leading the trial at the Seattle site. 鈥淲e鈥檙e really interested in enrolling patients as the first option,鈥� he said.

The questions are similar to those raised with hydroxychloroquine, another treatment Trump touted for treating COVID-19. FDA officials issued an , only to revoke it in June after data indicated the drug might be harmful.

鈥淥n a couple of occasions, we鈥檝e allowed clinical practice to get ahead of the science,鈥� Johnson said. 鈥淲e鈥檝e learned that lesson a couple of times now.鈥�

FDA officials did not respond to requests for comment.

Top federal health leaders, including NIH Director Dr. Francis Collins and Dr. Anthony Fauci, the nation鈥檚 leading infectious disease doctor, initially resisted the move to issue the EUA for convalescent plasma last month, telling that the evidence for it was too weak.

Trump has criticized the FDA for moving too slowly to speed approval of treatments and vaccines for COVID-19. He announced the EUA on the eve of the Republican National Convention, calling it a 鈥渢ruly historic announcement.鈥�

Issuing the EUA puts the fate of clinical trials into 鈥渆xtreme jeopardy,鈥� said Arthur Caplan, a professor of bioethics at the New York University School of Medicine. With convalescent plasma in very short supply, it sets the stage for fights over access and makes sick patients less inclined to join a trial, where they might receive a placebo.

鈥淚f you have the EUA, it starts to damage the trials,鈥� Caplan said.

Still, given that the FDA has authorized convalescent plasma for patients ill with COVID-19, hospitals that hesitate or refuse to provide it outside a trial are sure to face questions from families.

That creates 鈥渁 very interesting and delicate ethics problem,鈥� said Cohn.

鈥淚f you commit to the randomized controlled trial only, you鈥檙e committing to a long-term dedication to science,鈥� she said. 鈥淭he question is, is it ethically inappropriate not to provide a therapy that has been shown to be possibly beneficial?鈥�

Johnson, at the University of Washington, said most patients have been willing 鈥� even eager 鈥� to participate in clinical trials once they understand the need for rigorous scientific results.

And Caplan, the bioethicist, applauded the decision of hospitals to minimize the EUA and focus on the trial, calling it 鈥渁 pretty feisty action.鈥�

鈥淚t鈥檚 sensible,鈥� he said. 鈥淚t鈥檚 likely to really generate an answer to the question of 鈥楧oes COVID convalescent plasma do anything?鈥欌��