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F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say
A placebo control group was not even used in the 'convalescent plasma' Mayo Clinic study.
It seems Trump is pressuring and co-opting officials at the FDA to exaggerate test results and cut safety corners. Trump wants a COVID vaccine approved before the November election no matter what.
This is remarkably similar to how the Putin regime manages COVID. Massage the infection/death numbers, and then approve a vaccine before all phases of clinical trials are complete.
Related: 'Outrageous': Trump Announcement on Convalescent Plasma Blasted by Scientists
8/24/20
At a news conference on Sunday announcing the emergency approval of blood plasma for hospitalized Covid-19 patients, President Trump and two of his top health officials cited the same statistic: that the treatment had reduced deaths by 35 percent. 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.” 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. 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.
“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.” Dr. Robert Califf, who was F.D.A. commissioner under President Barack Obama, said on Twitter on Sunday that Dr. Hahn should correct his statement. Dr. Eric Topol, a professor of molecular medicine at Scripps Research in La Jolla, Calif. and a longtime expert in clinical trials, said that convalescent plasma has not yet shown the benefit that Dr. Hahn described — and that he should issue a correction. “He needs to come out with that, and until he does, he has no credibility as an F.D.A. commissioner,” Dr. Topol said. In an interview on Monday, one of the Mayo Clinic study’s main authors, Dr. Arturo Casadevall of Johns Hopkins University in Baltimore, said he was also stumped. “Do I know where the 35 percent comes from?” he said. “No.”
A placebo control group was not even used in the 'convalescent plasma' Mayo Clinic study.
It seems Trump is pressuring and co-opting officials at the FDA to exaggerate test results and cut safety corners. Trump wants a COVID vaccine approved before the November election no matter what.
This is remarkably similar to how the Putin regime manages COVID. Massage the infection/death numbers, and then approve a vaccine before all phases of clinical trials are complete.
Related: 'Outrageous': Trump Announcement on Convalescent Plasma Blasted by Scientists