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FDA chief declines feedback on coronavirus plasma therapy effectiveness

The Commissioner of the U.S. Food and Drug Administration, Dr. Stephen M. Hahn speaks during a press conference on the latest developments in coronavirus disease (COVID-19) in the Brady Press Briefing Room of the White House in Washington, USA, on August 23, 2020.

Erin Scott | Reuters

FDA Commissioner Dr. Based on comments on the benefits of convalescent plasma, Stephen Hahn says he could have explained the data on its effectiveness against the coronavirus better after allowing it for emergency use over the weekend.

Hahn was heavily criticized by scientists after saying at a White House press conference on Sunday that a study by the Mayo Clinic found that the treatment resulted in a 35% improvement in survival. However, in its approval, the agency cited more complicated findings from researchers at the Mayo Clinic on the use of plasma.

The study found that patients under 80 years of age who did not wear a respirator and received plasma with high levels of antibodies within three days of diagnosis were 35% more likely to survive an additional 30 days than those who received plasma with low levels Antibody content. One weakness of the Mayo study was that it did not include a controlled group of patients who received a placebo.

In a series of tweets on Monday evening, Hahn said the criticism from scientists was correct.

"I have been criticized for comments I made on Sunday evening about the benefits of convalescent plasma. The criticism is entirely justified," said Hahn. "What I should have said better is that the data shows relative risk reduction rather than absolute risk reduction."

The approval enables US healthcare providers to use the plasma to treat suspected or confirmed infections in hospital patients. The FDA's decision to approve emergency use came a day after President Donald Trump accused the agency of delaying entry into clinical trials for Covid-19 vaccines or therapeutics. Trump's criticism and the FDA's actions led some scholars to believe that the emergency deployment was politically motivated, especially since it was announced on the eve of the Republican National Convention.

Last week, Trump touted the benefits of the treatment, saying he had "heard great things about it," and then asked if bureaucratic opponents were slow to implement emergency clearance until after the November 3 elections.

Hahn said he did not bow to pressure from Trump. "The decision was made by FDA scientists based on data submitted a few weeks ago," Hahn tweeted on Monday evening.

During a Tuesday morning interview with CBS This Morning, Hahn again denied the change was made to appease the president, saying he could reassure Americans that the decision was made “based on sound science and data ".

"We looked at the Mayo Clinic data," he said. "The Mayo Clinic identified a group of patients, certain patients, who appeared to benefit the most, the antibodies to benefit them the most. We asked for additional validation data to support this, which meant the patients that they received high levels of antibodies versus those with low levels of antibodies. "

He added that he had a "very good relationship" with Trump and that he had spoken to him "several times this weekend".

"He wants us to focus on the urgency of this situation and move things forward, and I have great confidence in the 17,000 FDA staff who are great scientists, doctors and nurses that we will do it for the future." American. That's our promise to them, "Hahn told CBS.

The FDA had no additional comment.

There are no officially approved drugs or vaccines for the coronavirus. Convalescent plasma is one of several therapies being tested as a possible treatment. The plasma, taken from patients who have recovered from Covid-19 and who have developed antibodies to the virus, is infused into sick patients. Scientists hope it will boost the immune system in fighting the virus.

However, scientists and public health officials have doubts that more data from randomized controlled trials, considered the "gold standard" in science, is still needed to know whether they are safe and effective. The results of studies have been inconclusive, relatively poor, and provided "very poor quality evidence" according to the World Health Organization.

"We followed that up," said Dr. Soumya Swaminathan, WHO chief scientist, in Geneva on Monday. "We are doing ongoing meta-analyzes and systematic reviews to see where the evidence is shifting or showing, and at the moment it is still very poor quality evidence. We therefore recommend that convalescent plasma is still an experimental therapy. It should be well evaluated – designed, randomized, clinical trials. "

She said countries could use it in an emergency "if they feel the benefits outweigh the risks, but it usually does so while waiting for more definitive evidence that is pending."

Dr. Scott Wright, a cardiologist and a director of the Mayo Clinic's national plasma program, defended the FDA's decision, saying he didn't think she was "rushed".

"We are honestly pleased that you came to this conclusion because it is now making plasma available to every hospital and patient in the US and its territories," he told CNBC's "Squawk Box" on Tuesday.

The FDA has issued emergency clearance for several coronavirus tests and some drugs. In May, the agency approved antiviral remdesivir so that hospitals and doctors can use the drug on hospitalized Covid-19 patients. Hydroxychloroquine was also granted emergency approval, but the FDA later removed the name once the agency determined that the anti-malarial drug is unlikely to be effective.

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