FDA delay of blood plasma approval won’t slow local trials

By , Daily Memphian Updated: August 21, 2020 11:04 AM CT | Published: August 21, 2020 10:49 AM CT

The U.S. Food & Drug Administration’s decision to delay broader approval in use of blood plasma in COVID patients will have little to no effect on use of the treatment in Shelby County.


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Baptist Memorial Hospital-Memphis transfuses patients with blood plasma every day and will continue doing so, said Dr. Stephen Threlkeld, infectious disease expert who co-directs the hospital’s infectious disease center.

<strong>Dr. Stephen Threlkeld</strong>

Dr. Stephen Threlkeld

“We have done almost 850 plasma transfusions at our hospital. We were the first to it in the region. It just makes it easier with less paperwork and less oversight when the FDA gives a wider approval,” he said.

Epidemiologists who advise the U.S. government, including Dr. Francis Collins and Dr. Anthony Fauci, said data from clinical trials, including results of 35,000 people in a trial conducted by the Mayo Clinic, did not show strong enough findings to warrant emergency approval.

But the trial did show some promising results, Threlkeld said, including that strong doses of antibody plasma given early in the disease helped more than “if you gave it later or with lower amounts of antibodies.”

“All that is encouraging. A transfusion of a good antibody plasma is going to be helpful in the early stages. Most antibody treatments we do for people, immune globulin and others, tend to be better when given early. That is not a surprise to anyone in infectious disease,” he said.

“The problem is, we need to make sure these things are safe before we unleash wider-scale use.”

In the spring, the FDA approved use of the therapy in clinical trials across the nation. Baptist Memorial Health Care and Methodist Le Bonheur joined the Mayo study. The University of Tennessee Health Science Center in Memphis is conducting its own trial.

The therapy uses plasma from people who have had COVID-19 and developed antibodies. The fluid is transfused into patients who are sick with the disease in the hospital.

<strong>Dr. Jon McCullers</strong>

Dr. Jon McCullers

“It is still being done on a research basis,” said Dr. Jon McCullers, chair of the Department of Pediatrics in the College of Medicine at UTHSC and pediatrician in chief at Le Bonheur Children’s Hospital. “Research hospitals will keep on doing what they are doing, but it cannot be commercialized or used more widespread.”

For now, rural and community hospitals not connected to a research center will not be able to start the treatment. Under a wider approval, they would have.


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“The Mayo Clinic study is still continuing, as is our participation in the study,” said Sarah Farley, Methodist spokeswoman.

Both Baptist and Methodist continue to accept blood plasma donors.

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The results UT and its clinical partners are seeing are anecdotal at this point, McCullers said.

“Some patients certainly got better after getting antibodies but overall, there isn’t an appreciable large-magnitude change. It’s not like a magic bullet when people get better once you give them the antibodies.”

That could change, he said, if the studies were targeted to patients who doctors thought would get the most benefit.

“These clinical trials are very difficult to do because you take all comers. Blood plasma probably only helps a subset of patients, maybe before they got sick,” McCullers said. “It would be hard to design a trial that would specifically zero in on those I expect it would help.”

The existing trials did not include a control group.

Threlkeld sees very little controversy in the decision to delay emergency approval.

“It’s typical that we like to see controlled data. We like to know what this does in a randomized fashion. We want to know we are comparing apples to apples when we really say that something cuts mortality or length of disease or severity of illness,” he said. “Those kinds of data are not quite there yet.”

This spring, FDA granted emergency-use approval for hydroxychloroquine, a drug originally developed to fight malaria, and had to walk the approval back when the drug, also used for rheumatoid arthritis and some symptoms of Lupus, showed little or no efficacy against COVID.


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The FDA has also granted emergency-use approval for remdesivir and other existing drugs for use in COVID.

<strong>Dr. Jeff Warren</strong>

Dr. Jeff Warren

“My thought is they have been letting a lot of things go, experimental things,” said Memphis Dr. Jeff Warren, who is also a City Council member. “They have been collecting data on blood plasma. It may be that it is not showing progress.” 

McCullers agrees there is a sensitivity at FDA about treatments, such as hydroxychloroquine, which he said early on should never have been approved.

“I don’t believe that would impact this. Blood plasma is not a novel new therapy.

“I think the issue is more a thorough, more-structured, better-controlled study with less noise so you are better able to get a true answer,” McCullers said.

Clinical trials require physicians to carefully document all the findings, including demographic information of the recipients and their medical history.

“While it would be nice to cut down on the paperwork associated with a clinical trial,” Threlkeld says, “we are not feeling any crunch that we cannot get this product because of the decision.

“In no way is the decision not to move ahead with emergency approval by the FDA going to stop people from getting this product.

“Not at all. We are continuing to do it today and have been doing it for some time now.”

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Stephen Threlkeld Dr. Jon McCullers blood plasma FDA approval emergency-use authorization coronavirus treatment
Jane Roberts

Jane Roberts

Longtime journalist Jane Roberts is a Minnesotan by birth and a Memphian by choice. She's lived and reported in the city more than two decades. She covers healthcare and higher education for The Daily Memphian.


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