“For the first time ever, I feel like official people in communications and people at the F.D.A. grossly misrepresented data about a therapy,” said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
It is especially worrisome, he said, given concerns over how Mr. Trump has appeared to politicize the process of approving treatments and vaccines for the coronavirus. Over the next couple of months, as data emerges from vaccine clinical trials, the safety of potentially millions of people will rely on the scientific judgment of the F.D.A. “That’s a problem if they’re starting to exaggerate data,” Dr. Gellad said. “That’s the big problem.”
VT: Worse still, the US just sent combat aircraft across the Russian border in an attempt to cause an incident there and just did the same with China, all to bolster convention numbers…
The FDA literally refused to approve plasma for covid not 4 days ago. Trump, with zero scientific background, overruled the doctors at the FDA because he knows more.https://t.co/HjL542yXis pic.twitter.com/rFQUywYHAx
— John Aravosis 🇺🇸🇬🇷🏳️🌈 (@aravosis) August 23, 2020
Putin announced his fake “vaccine breakthrough!” without studies and became (yet again) an international laughingstock.
Now we’ll do the Trump/U.S. version on therapeutics: https://t.co/gGOLnqtvS4
— Rachel Maddow MSNBC (@maddow) August 23, 2020
Mr. Trump called it a “tremendous” number. His health and human services secretary, Alex M. Azar II, a former pharmaceutical executive, said, “I don’t want you to gloss over this number.” And Dr. Stephen M. Hahn, the commissioner of the Food and Drug Administration, said 35 out of 100 Covid-19 patients “would have been saved because of the administration of plasma.”
FDA chief walks back his claim that an experimental therapy, convalescent plasma, had provided a dramatic benefit to coronavirus patients.
He was pressured by Trump to say it in the first place.https://t.co/eHxES34zSR
— LiA (@LibsInAmerica) August 25, 2020
But scientists were taken aback by the way the administration framed this data, which appeared to have been calculated based on a small subgroup of hospitalized Covid-19 patients in a Mayo Clinic study: those who were under 80 years old, not on ventilators and received plasma known to contain high levels of virus-fighting antibodies within three days of diagnosis.
I knew it.
Convalescent plasma been used in 90,000 ppl. Data's not been good, so FDA pulled back. Four days ago, FOX started harping that the FDA was blocking a miracle treatment. Yesterday, Trump repeated Fox. Today, he's going to hype what Fox hyped. https://t.co/qixUnsvtwD
— Kurt "Masks Save Lives" Eichenwald (@kurteichenwald) August 23, 2020
What’s more, many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about where the statistic came from. The number was not mentioned in the official authorization letter issued by the agency, nor was it in a 17-page memo written by F.D.A. scientists. It was not in an analysis conducted by the Mayo Clinic that has been frequently cited by the administration.read more…<
Trump, and his appointees FDA’s Hahn and HHS Azar appear to have made up a number not in the study on Sunday.https://t.co/283FeBm4DS
— Amy Siskind 🏳️🌈 (@Amy_Siskind) August 25, 2020
FDA Commissioner Stephen Hahn conceded that he overstated the results of using convalescent plasma on coronavirus patients https://t.co/9H9PBGObaa
— The Daily Beast (@thedailybeast) August 25, 2020