In a move health experts have criticized as unscientific, the Food and Drug Administration issued an emergency authorization for blood plasma transfusion as a treatment for COVID-19.

“The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from COVID-19,” U.S. Department of Health and Human Services Secretary Alex Azar said in a press announcement Sunday, Aug. 23.

Some see it as a different kind of milestone, though. Dr. Craig Klugman, a health sciences professor at DePaul, said this could leave the FDA with a black eye that lasts decades, similar to the botched handling of the 1976 bird flu outbreak — which he says is one of the factors that helped spawn the anti-vax movement.

“There were public statements by [Trump] to his administration that the FDA was trying to make him look bad by not approving this,” Klugman said. “So now, it’s not a question of the science. It’s a question of, is the FDA — which has been the most trusted agency in the world for protecting our health, for food and drugs — are they now making decisions based on politics instead of science?”

FDA Commissioner Steven Hahn claimed on Aug. 23 that the blood plasma treatments would save 35 out of every 100 people who receive them, citing a records analysis that used data from past studies. After many in the scientific community lashed out at Hahn’s claim for being both deeply misleading and relying on a study that hasn’t yet been peer-reviewed, Hahn tweeted an apology, saying the criticism “is entirely justified.”

Cutting corners and skipping steps

Typically, the FDA approves treatments only after they clear an exhaustive set of hurdles designed to prove that they’re safe and that they work effectively. Multiple stages of trials — including some that are lengthy, randomized and placebo-controlled — are considered the most surefire way to do that.

The analysis Hahn cited, however, failed to meet that standard. 

“What they did was a retrospective study, they looked at the records,” Klugman said. “So there could be differences in how things were recorded, and the data that was available. You can’t control for all the variables.”

Apples to oranges, in other words.

“That makes it less trustworthy in terms of data,” Klugman said, “so we tend not to approve things based on retrospective records analysis.”

Not only that, but full FDA approval through a clinical trial involves three phases, with an ongoing fourth phase of monitoring after a drug is approved.

Phase one determines if a treatment is safe — when given to healthy people, does it cause harm? Phase two determines if a treatment is effective — do COVID-19 patients see improvement when given this treatment? Phase three has multiple goals, but ultimately determines what dosage should be used — are there harmful side effects, for example, in too large a dose?

Blood plasma treatment for COVID-19 has gone through none of these phases. 

To make matters worse, the FDA’s emergency authorization hamstrings any attempt at putting the treatment through these clinical trial phases.

Imagine you’re a doctor trying to enroll participants in one of these studies to make sure blood plasma treatment is safe and effective. The way you find these participants is by telling people there’s a new treatment that has a good chance of working against COVID-19 — and if they take part in this study, they’ll have a 50% chance of getting this treatment (the other 50% gets a placebo).

Now, imagine you’re that same doctor trying to recruit the same patients today. Every one of them can simply get their doctor to prescribe them the blood plasma treatment, now that the FDA has granted the emergency authorization.

“It makes it harder, or impossible, to do the studies that need to be done because who wants a 50% chance they’re going to get [a placebo]?” Klugman said. “So the risk here is that we’ll actually never have the data to know if this works or not.”

Borrowing your neighbor’s immunity

When you get a virus, your body has evolved to produce antibodies that prevent it from running rampant in your system. Some people’s bodies are better at making antibodies than others.

“You’ve seen all the pictures of the virus with the little spikes that stick out,” said Dr. Phillip Funk, an immunology professor at DePaul and an expert in the cells that make antibodies. “You can think of that spike as being a key that allows the virus access into your cells.”

Once a virus breaks into your cells, it does what viruses do — replicate.

“That’s really the infection,” Funk said. “What an antibody does is, an antibody sticks onto that spike on the virus.”

Kind of like child-proofing a house, antibodies cover up those sharp points on the virus and prevent it from piercing into the cell, thereby stopping it from replicating (and often “eating” the virus particle itself!). Not everyone’s body, however, is good at mounting this defense.

Blood plasma treatment is a way of getting someone else’s antibodies to hold down the fort while your body mounts its own defenses. A doctor takes blood from someone whose body fought off a virus, separates out the antibodies, and injects them into a person whose body is struggling to fight the same virus.

“So this is a thing that, I mean, there is a history of this as a strategy,” Funk said. “It’s not clear that it works in every case, but it does work in some.”

Again, this kind of treatment for COVID-19 currently falls into that first category: it’s not clear that it works.

“[Convalescent blood plasma treatment] can be a good thing to use,” Klugman said. “The danger in something like COVID is, we have nothing. We don’t know the side-effect profile of it yet, and we don’t actually know if it’s effective.”

Erosion of trust

On Aug. 22, President Trump tweeted accusations of deep-state influence at the FDA, saying the agency was trying to undermine his reelection efforts by slow-playing the process for vaccines and treatments.

The next day, the agency announced the emergency authorization of little-studied blood plasma treatments for COVID-19, and agency commissioner Hahn made that dubious and unverified claim that he’s since walked back slightly.

“Look, when we’re talking about human lives here, the potential of bad science, the potential of misinterpreting the science, is that people get hurt or die,” Klugman said.

The CDC and FDA slowly built up their now-sterling reputations over 100 years — reputations that Klugman said the current administration has tarnished “within a couple of months.”

“In fact, when DePaul was … deciding who we listen to about masks or testing, and whose data is best, I went to the WHO,” Klugman said. “I went to the World Health Organization because it struck me that the CDC was not as dependable as it traditionally has been.”

The CDC posted an update to its guidelines, recommending fewer Americans get tested for COVID-19, the day after the FDA’s blood plasma authorization. Public health experts have widely condemned the updated guidelines.

“The FDA has been the gold standard around the world, that, you know, if the U.S. system approves something, it has done its job,” Klugman said. “It’s what we call due diligence. It has done good research, and you can trust it.”

Now, however, the FDA’s status as the global gold standard seems to be fading.

“With convalescent plasma treatment, we don’t know anymore,” Klugman said. “How do you trust them now?”

As of Sept. 8, more than 174,000 Americans have died from the coronavirus.

Note: This story has been updated to clarify details in the drug-approval process and the body’s immune responses.