- A new coronavirus treatment might be more widely available to patients, but it’s not the breakthrough the world might need.
- Convalescent plasma transfusions can save lives in severe COVID-19 patients, but it’s not the miracle cure that can save everyone.
- The therapy has received emergency use approval, with President Trump touting it as a “historic breakthrough.”
- Other health officials aren’t convinced, as plasma transfusions have been found to work only in certain conditions. One other limitation is that none of the current studies have had a placebo control group, so the conclusions might not be entirely accurate.
After eight months of dealing with the novel coronavirus pandemic, the world has a few therapies that can reduce complications and can save lives. Dozens of other drugs are in various stages of clinical testing, and more than 150 experimental vaccine candidates are also in the works — of those, a handful of them have reached the critical Phase 3. The drugs that can save lives do not work on all patients who develop severe complications that can lead to death, however. There’s no miracle cure that can save everyone. Also, as long as the infectivity rate remains high, the death rate will remain high as well. It’s not only that the drugs aren’t effective in all patients. It’s also the strain on resources, including personnel, therapies, and devices, that can put a person’s life at risk.
Another therapy joins the list of treatments that can improve the condition of COVID-19 patients, and that’s something we’ve often discussed in the past few months. Antibody-reach blood plasma has just received emergency use authorization (EUA) from the Food and Drug Administration (FDA) after reports said the approval had been put on hold. Sadly, like hydroxychloroquine, convalescent plasma is also being politicized. President Trump is touting it as a major breakthrough, hinting that it could save many lives. The problem with the EUA is that plasma hasn’t gone through a proper study either. The benefits may be limited, recent studies have shown, and plasma won’t save everyone. Thankfully, unlike hydroxychloroquine, plasma transfusions will not put anyone’s lives at risk.
Studies from the Houston Methodist hospitals and the Mayo Clinic have shown that plasma from COVID-19 survivors can save the lives of people experiencing coronavirus complications under two specific limitations. The treatment has to be applied early in the disease, and the plasma has to be rich in antibodies to work. This therapy also has a third essential limitation. For plasma to work, hospitals need plenty of donors that match with severe patients.
President Trump announced the plasma EUA on Sunday afternoon, calling it a “truly historic announcement,” per Stat. “Today’s action will dramatically expand access to this treatment,” he said, adding that convalescent plasma has been proven to reduce mortality by 35%. He called it a “tremendous number.”
“We dream in drug development of something like a 35% mortality reduction,” Health and Human Services Secretary Alex Azar said. “This is a major advance in the treatment of patients.”
Unfortunately, it’s unclear where that 35% figure comes from. The FDA staffer who reviewed the data wasn’t as enthusiastic, and the person’s name was redacted from a memo the agency released.
The data “support the conclusion that [convalescent plasma] to treat hospitalized patients with COVID-19 meets the ‘may be effective’ criteria for issuance of a EUA. Adequate and well-controlled randomized trials remain nonetheless necessary for a definitive demonstration of… efficacy and to determine the optimal product attributes and the appropriate patient populations for its use,” this person said.
A few days ago, we learned that several health officials, including Dr. Anthony Fauci, opposed the EUA for plasma citing unconvincing evidence. None of the existing studies had placebo controls, as highlighted by the quote from the FDA staffer above. Furthermore, EUA approval might make it difficult for anyone to agree to take part in a study where they might be given a placebo instead of the actual plasma. But, again, these studies have shown that not all patients who are given plasma will survive, and people should understand that the risk of death is still there even after plasma transfusions. The therapy has limitations that no amount of enthusiasm should ignore.
Former FDA commissioner Scott Gottlieb defended the FDA against Trump’s Twitter remarks that the agency may have delayed the approval of plasma, CBS News reports. He also made it clear that the trials so far do not meet medical standards yet.
“The trial that that’s going to be based on, 70,000 patients, wasn’t a very rigorously done trial. It was an open-label study where everyone got treated, so it’s hard to draw conclusions,” he told CBS. “I believe plasma is probably beneficial. It’s probably weakly beneficial in the setting of this treatment. But I think some people wanted to see more rigorous data to ground that decision. And I think that’s part of what is going on here with respect to that tweet and questions about the FDA decision-making.”
The best way of preventing COVID-19 complications remains avoiding the infection.