FDA denies emergency authorization for COVID-19 plasma treatment, a lifesaver for some

The FDA has not approved emergency authorization for plasma to treat COVID-19 due to a lack of data. However, it could be approved later.

We spoke with one woman who said, for her, plasma was a lifesaver.

Stacie Rathel and her family have experienced the mild and scary sides of the coronavirus. She and her daughter beat it no problem, but her husband Michael, not so much.

“Forty-eight hours later, less than, he was put on a ventilator, in a coma and in intensive care,” Rathel said.

Michael did not respond to treatment, so she begged doctors to try convalescent plasma.

“This is my husband, this is my children’s father, and we want him to live,” she said.

This was back in March when COVID-19 was new and plasma donors were rare, but Rathel found one.

“So by Easter morning, he woke up. He woke up out of a coma and that was our Easter miracle,” she said.

Here we are now in August and the FDA said it will not yet approve of convalescent plasma treatments because there’s not enough evidence that it works.

This doesn’t mean doctors can’t use plasma, just that scientists need definitive proof.

“What I don’t have is that, does it make a difference at 30 days,” explained Dr. Kirk Voeljer, the medical director at Sarasota Memorial. He’s also part of the Mayo Clinic clinical trial.

He explained the problem this way: “For us to really get an idea of whether it’s working, you have to do a real clinical trial in which you compare it to people not receiving that medication.”

In the Mayo Clinic trial, everyone who enrolls gets the treatment.

“It is mind-boggling to me why there is red tape and all,” Rathel said. “It’s really people’s lives and it’s so urgent.”