Plasma therapy OK’d for COVID
Under pressure from Trump, FDA approves transfusion treatment
President Donald Trump on Sunday announced the emergency-use authorization of convalescent blood plasma as a treatment for COVID-19, a move that will enable all hospitals to deploy the popular but not wellproven therapy.
At a news conference a day ahead of the Republican National Convention, Trump called the Food and Drug Administration authorization a “breakthrough” that’s about life and death, not politics. The authorization was issued a few days after he complained the FDA was guilty of politically motivated delays.
“This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection,” said Trump, who added later in the news conference that the political “logjam” was broken in the past week. “Today’s action will dramatically expand access to this treatment.”
The authorization comes less than a week after UTHealth and Baylor College of Medicine began enrolling participants in more rigorous studies investigating the therapy, studies many scientists thought were needed to facilitate greater use of the treatment. Because of the lack of such data, the FDA last week put the plan to issue the emergencyuse authorization on hold.
The treatment is based on the premise that transfusing plasma from patients who’ve recovered from a virus transfers its healing powers, contained in antibodies made by the immune system to attack the infection. First used during the 1918 Spanish influenza, it has become one of the go-to treatments for the disease caused by the coronavirus.
Some experts immediately criticized the emergency authorization, arguing the evidence for the therapy remains inconclusive without results from a test randomly assigning
participants into one group that receives blood plasma and another that gets a placebo or some standard of care. Some who said they think it will provide a benefit said it is far from the “breakthrough” Trump touted it to be.
“I’m very disappointed in the FDA and with the political intervention,” said Dr. Paul Klotman, president of Baylor College of Medicine. “We need the right randomized study to determine efficacy. Every time we do something that isn’t proven, there is the potential to waste time, money and lives.”
Klotman, who called the authorization premature, noted that it was made despite advice to the contrary by the directors of the National Institutes of Health and National Institute of Allergy and Infectious Diseases. It was reportedly those two — Francis Collins and Anthony Fauci, respectively — who’d convinced the FDA to put a hold on an emergency-use authorization, arguing the existing data is not strong enough.
But Dr. James Musser, a Methodist professor of pathology and genomic medicine who has led the Houston hospital’s research with the therapy, said Sunday “the FDA made the best decision it could with the available data.” Methodist and Mount Sinai in New York were the nation’s first U.S. hospitals to provide the therapy, both transfusing patients with plasma on the same night in March.
“There have been a variety of trials, all pointing in the same direction — that blood plasma with high levels of antibodies and given early in the disease benefit patients,” Musser said. “It’s important to get randomized trials done, but they’re not perfect.”
Ed Jones, the head of the Houston Methodist Research Institute, last week expressed disappointment that the expanded access was delayed. He said Methodist was eager to deploy the therapy at its suburban hospitals, which aren’t able to make available to patient therapies in clinical trials, like hospitals in the Texas Medical Center.
Trials involving plasma therapy include one by Methodist published in the Journal of Pathology earlier this month. It found that 136 patients who received plasma were more likely to be alive four weeks later than 251 patients who did not receive it. The latter group did not receive a placebo; researchers instead compared patients who got plasma with similar patients based on medical records.
Dr. Stephen Hahn, the director of the FDA, touted at the news conference that studies of the therapy have found a 35 percent survival benefit, which he called “pretty significant.”
Much of the work was through a large trial led by
the Mayo Clinic. About 35,000 COVID-19 patients got plasma in that trial, which also did not involve a placebo. Like the Methodist trial, patients who got plasma in it were compared with similar patients not enrolled in the trial.
But despite the emergency authorization, there will be limits to access to the therapy, simply because plasma is derived from blood donations and can’t be ramped up into millions of doses like a synthetic drug. Though Trump said donations have doubled since the administration launched a campaign urging recovered patients to donate, blood bank officials around the nation have lamented their supply is limited.
Peter Hotez, a Baylor infectious disease specialist, called the authorization a “modest benefit,” noting the limited availability of plasma and the need to give it in adequate amounts and early in the course of disease. But he acknowledged the emergency authorization should reduce the amount of paperwork and time required to get access to the therapy.
In the authorization letter, FDA officials stressed the therapy is still under investigation.
“Convalescent plasma should not be considered a new standard of care for the treatment of patients with COVID-19,” said the letter. “Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months.”
The FDA, which has issued many emergency-use authorizations during the pandemic, can always rescind such orders. It did that with hydroxychloroquine, the antimalaria drug Trump and others advocated for COVID-19 that was ultimately found to be ineffective in trials.
New York University and Montefiore Medical Center/ Albert Einstein College of Medicine are leading the new randomized, placebo-controlled study, considered the gold standard of drug testing. UTHealth joined that study last week.
“This is exactly the study we need to be doing to determine once and for all if this therapy works,” said Dr. Luis Ostrosky, study co-investigator and infectious disease specialist at McGovern Medical School at UTHealth. “Physicians have been using the therapy to try to save patients during the pandemic, knowing it’s safe but not knowing if it really works. Now, we’re going to find that out.”
Ostrosky, also an infectious disease doctor at Memorial Hermann, said he expects UTHealth will finish enrollment of patients by the end of the year. It expects to supply about 400 of the trial’s 1,300 patients.