FDA Official Apologizes After Misrepresenting Data Regarding Blood Plasma As COVID-19 Treatment

August 26, 2020 Updated: August 26, 2020

An FDA health official issued an apology on Monday, after admitting he had overstated the benefits of blood plasma for COVID-19 treatment.

Dr. Stephen Hahn, the commissioner for the U.S. Food and Drug Administration, stated that he had misrepresented an important data set regarding the effectiveness of blood plasma for treating COVID-19 in a news release issued on Sunday.

According to Medical XPress, following the press briefing that took place on Sunday, Hahn and other health officials came under fire for stating that blood plasma from recovered COVID-19 patients had the ability to reduce the mortality rate of currently infected patients by 35 percent.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction, not an absolute risk reduction,” Hahn said in a series of tweets.

Hahn also commented on the decision to allow for the emergency usage of blood plasma, writing that the decision was made by FDA scientists based on data regarding blood plasma. Hahn said that the scientists in the FDA “had confidence that the convalescent plasma has potential to benefit many sick patients and the safety profile is well defined.”

The data was sourced from the Mayo Clinic, Hahn stated, as well as prior experiences regarding blood plasma because the FDA itself did not have any randomized trials for the blood plasma program.

Hahn further reassured the public about the decisions made, stating that the FDA is driven by data, and that just because blood plasma is authorized for usage in emergency cases, it is by no means a final decision.

“FDA will continue to monitor its use and will revoke an authorization if needed. We feel broader usage of plasma will truly benefit many patients but will require further study,” Hahn said.

The FDA press release initially stated that the data that was sourced “suggests that patients who were treated early in their disease course—within 3 days of being diagnosed—with plasma containing high levels of antibodies benefited the most from treatment,” and that the scientists “saw about a 35 percent better survival in the patients who benefited most from the treatment—which were patients under 80 who were not on artificial respiration.”

Convalescent plasma is the treatment that involves the use of blood plasma collected from recovered COVID-19 patients which contains antibodies. The FDA stated that this method has been used in the past for other respiratory diseases, such as the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic.

According to the FDA, blood plasma does seem like a promising development in the effort to treat COVID-19, however not enough information and research have gone into its effectiveness.