U.S. FDA Commisioner Apologizes Over False Plasma Data

The coronavirus crisis has led scientists and researchers to look out for every possible medical solution. Until the vaccine doesn’t roll out, doctors have asked for recovered coronavirus patients to donate their blood plasma to treat the Covid-19 patients.

On Monday, Dr. Stephen Hahn, the commissioner of the US Food and Drug Administration (FDA), apologized after announcing an explicit percentage in mortality reduction after the usage of blood plasma antibodies in inflicted patients. Other senior health officials including him were criticized for stating the false data. The health officials repeated the same data after Trump said at a press conference on Sunday that plasma antibodies were “proven to reduce the mortality by 35 percent.”

“What that means is- and if the data continues to pan out- 100 people who are sick with Covid-19, 35 would have been saved because of the administration of plasma,” Dr. Hahn said on a Sunday. After the evaluation of the data, the statistics were proven to be false. The FDA officials told AFP that these results came out from the study conducted on 35,000 patients in Mayo Clinic and not from their institute. They added that he believed that it was an “integrated analysis” after looking at Mayo’s and other studies.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Dr. Hahn said in a tweet thread on Monday night. “The criticism is entirely justified. What should I have done better is that the data show a relative risk reduction, not an absolute risk reduction.” The FDA spokesperson Emily Miller also backed him by tweeting his entire thread to clear the confusion among the users.

Currently, scientific institutions are divided on the effective use of plasma for treating Covid-19 patients. The commissioner said in a tweet that “FDA will continue to monitor its use and will revoke authorization if needed.”  The FDA has approved the use of plasma but under certain conditions. As of now, it has given “emergency use authorization” rather than its complete approval.

Various countries are using plasma antibodies for the treatment. For instance, a recent UK analysis stated that the use of plasma is “very certain” for the coronavirus crisis. According to the World Health Organization (WHO) officials, the use of convalescent plasma is “still an experimental treatment.” Meanwhile, Soumya Swaminathan, chief scientist at WHO said that “There are a number of clinical trials going on around the world looking at convalescent plasma compared to the standard one. Only a few of them have actually reported interim reports…and at the moment, it’s still very low-quality evidence.”

Latest on Covid-19 Vaccines

Recently, Russia said that it has registered its first Covid-19 vaccine; however, it has been under the attack for approving the vaccine without completing the mandatory tests. Moreover, China has approved the usage of the Covid-19 vaccine under emergency scenarios has been approved. Meanwhile, the eminent virus expert and head of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci told to Reuters that rushing out vaccines can hamper other trials.