October 28, 2020 04:03 AM RSS

FDA Chief Apologizes: Plasma Treatment Not Breakthrough

  • Wall Street Rebel | James DiGeorgia
  • 08/25/2020 2:06 PM
FDA Chief Apologizes: Plasma Treatment Not Breakthrough

Another day, another life and death lie by President Trump exposed. After a rushed White House and FDA announcement on Sunday announcing a new therapeutic breakthrough for treating COVID-19. The FDA disavows the claim.

 

New Postmaster General Louis DeJoy committed perjury in front of the House Oversight and Reform Committee directly contradicting a written statement he sent out to postal workers.  In DeJoy’s first 70 days, he admitted that he sent written orders that resulted in the “unforeseen consequence” of slowing mail delivery. However, while testifying at the House Oversight and Reform Committee, he said he didn’t know who ordered the changes.

The Food and Drug Administration Commissioner (FDA) Stephen Hahn was preparing to release a statement apologizing for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma announced by President Trump and the FDA on Sunday.

“Overstating” is nice way of wording that it was an outright lie manipulated pressured by the White House for purely political purposes to aid in the re-election of the president. 

Live 42% longer and still eat loads of cheese, breads, and rich desserts?Immediately, after Sunday’s “breakthrough” White House press conference, scientists and medical experts began pushing back against the claims about the plasma treatment.  The FDA had decided to issue an emergency authorization for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in antibodies.

At the Sunday news conference, President Trump falsely hailed the decision by the FDA to authorize the use of the convalescent plasma treatment as a historic breakthrough even though the treatment’s value has absolutely not been established.

 The announcement on the eve of Trump’s Republican National Convention was entirely politically motivated and intended to offset the cacophony of criticism of the president’s handling of the pandemic. Even though the claim this treatment was a breakthrough was an outright lie.

Hahn went along with the political theater echoing President Trump’s claim that that 35 more people out of 100 would survive the coronavirus if treated with the plasma. That claim has now been proven to overstate the preliminary findings of Mayo Clinic’s observation vastly and drew condemnation from other scientists and some former FDA officials, who demanded Hahn to correct the record.

Hahn response today via Tweet…

 “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,”

The FDA made the decision based on data the Mayo Clinic collected from hospitals around the country that were using plasma on patients in wildly varying ways. There was no comparison group of untreated patients, meaning no conclusions can be drawn about overall survival. This means that even with Dr. Hahn’s walk back on Trump’s claim (see video below), his claim that the decision by the FDA to authorize convalescent plasma treatments for COVID-19 patients was not based on data.

Dr. Peter Lurie, a former FDA official under the Obama administration who now leads the nonprofit Center for Science in the Public Interest, was quoted as saying…

“It’s extraordinary to me that a person involved in clinical trials could make that mistake, it’s mind-boggling.”

While Dr. Hahn has been endeavoring to reassure confidence in the agency’s scientific process in interviews and articles and assuring the public, the FDA will not approve any vaccine or treatment that doesn’t meet a predetermined regime of standards for safety and efficacy.

Dr. Lurie pulled no punches and said Hahn’s performance at the press conference undermined his credibility, particularly among FDA staff…

“I think within the agency, his credibility is massively reduced as a result.”

House Speaker Nancy Pelosi, a Democrat, called Dr. Hahn a “disappointment” and said House committees were looking into FDA actions.

Trump has been doing everything he can to politicize the FDA and bend it to his political purposes by accusing FDA staff, without evidence, of deliberately holding up new treatments “for political reasons.” Mark Meadows echoed the pressure by literally saying over the weekend that FDA scientists “need to feel the heat.”

At Sunday’s briefing, Dr. Hahn stood alongside President Trump and did not attempt to correct Trump’s description of the regulatory move as a “breakthrough.” Worse Hahn stood by Trump without contradicting his unsupported claim of a “deep state” effort at the agency working to slow down approvals.

Dr. Jesse Goodman of Georgetown University, who previously served as FDA’s chief scientist, was quoted by Associated Press as saying…

“I think the constant pressure, the name-calling, the perception that decisions are made under pressure is damaging.” “We need the American people to have full confidence that medicines and vaccines are safe.”

The truth about convalescent plasma is it’s a century-old approach to treating the flu, measles, and other viruses. But the evidence so far has not been conclusive about whether it works, when to administer it, and what dose is needed. So far, 70,000 Americans have received the therapy under FDA’s “expanded access” program. That program tracks patients’ response, but cannot prove whether the convalescent plasma played a role in their recovery.

The FDA emergency authorization is expected to increase its availability to additional hospitals. Still, many scientists, medical researchers, and front line physicians worry the broadened FDA access to the treatment will make it harder to complete studies of whether the treatment actually works. Legitimate studies of convalescent plasma require randomizing patients to either receive plasma or dummy infusions.

 

                     DA Commissioner Hahn responds to criticism




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