“We Don’t Have Enough Data”
“I Watched This in Horror”
Trump “Has Lost Total Credibility” on COVID-19 Treatments
Jonathan Reiner, A Professor Of Medicine At George Washington University: The Problem Is, We Don’t Really Have Enough Data To Really Understand How Effective Convalescent Plasma Is.”
- “‘The problem is, we don’t really have enough data to really understand how effective convalescent plasma is,’ Dr. Jonathan Reiner, a professor of medicine at George Washington University and a CNN medical analyst, said Sunday.” [CNN, 8/23/20]
Dr. Paul Offit, Director Of The Vaccine Education Center At Children’s Hospital Of Philadelphia: “I Think What’s Happening Here Is You’re Seeing Bullying, At Least At The Highest Level Of The FDA.”
- “Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said he thought it likely the White House pressured the FDA into pushing through the EUA. ‘I think what’s happening here is you’re seeing bullying, at least at the highest level of the FDA, and I’m sure that there are people at the FDA right now who are the workers there that are as upset about this as I am,’ Offit told CNN’s Wolf Blitzer.” [CNN, 8/23/20]
Dr. Thomas File, President Of The Infectious Diseases Society Of America: “We Lack The Randomized Controlled Trial Data We Need To Better Understand [Plasma’s] Utility In Covid-19 Treatment.”
- “‘While the data to date show some positive signals that convalescent plasma can be helpful in treating individuals with COVID-19, especially if given early in the trajectory of disease, we lack the randomized controlled trial data we need to better understand its utility in COVID-19 treatment,’ Dr. Thomas File, president of the Infectious Diseases Society of America, said in a statement.” [CNN, 8/23/20]
Dr. Joshua Sharfstein, Vice Dean At Johns Hopkins University’s School Of Public Health: “I Was Horrified… This Is A Promising Therapy That Has Not Been Fully Established.”
- “‘The FDA commissioner basically allowed the president to mischaracterize the decision and attack the integrity of FDA employees. I was horrified,’ said [Dr. Joshua] Sharfstein, a vice dean at John Hopkins University’s school of public health who was a top FDA official during the Obama administration.’This is a promising therapy that has not been fully established,’ he said.” [NBC Chicago, 8/23/20]
Benjamin Corb, The American Society For Biochemistry And Molecular Biology: The Emergency Use Authorization Is “Conspicuous Timing.”
- “Benjamin Corb, of the American Society for Biochemistry and Molecular Biology, called it ‘conspicuous timing…’ ‘President Trump is once again putting his political goals ahead of the health and well-being of the American public,’ Corb said.” [NBC Chicago, 8/23/20]
Dr. Vivek Murthy, Former Surgeon General Of The United States: “If An [Emergency Use Authorization] For [A] Vaccine Is Managed Like Today’s Convalescent Plasma Treatment, We Are In Trouble.”
- “If an EUA for #COVID19 vaccine is managed like today’s convalescent plasma announcement, we are in trouble. We need to know the process for evaluating safety/efficacy is based on science not politics. Today’s announcement did not provide that assurance. We must do better… CP may work. It is unlikely to be a game-changer, but it may have modest impact. Unanswered questions: does it reduce mortality, who will benefit most, what dose/duration is best, what kind of antibodies matter. We still don’t have quality data to answer these questions… Regardless of whether CP works, the integrity of the evaluation process also matters. Process is what makes the difference between public trust and public skepticism. If people distrust the evaluation process with treatments, they may question the process with vaccines.” [Twitter, @vivek_murthy, 8/23/20]
Dr. Eric Topol, Director Of The Scripps Research Translational Institute: “I Watched This In Horror.”
- “‘I watched this in horror,’ said Eric Topol, an influential physician and scientist and director of the Scripps Research Translational Institute. ‘These are basically just exploratory analyses that don’t prove anything. It’s just extraordinary to declare this as a breakthrough … All this does is jeopardize ever getting the truth.’” [Washington Post, 8/23/20]
Peter Bach, Director Of Memorial Sloan Kettering’s Center For Health Policy Outcomes: The Crisis Has Combined With A “False Sense” That Studies Should Be Skipped.
- “‘The urgency of the crisis has elided with a false sense we should skip over rigorous studies of interventions because we don’t have enough time,’ said Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes.” [Washington Post, 8/23/20]
Carlos Del Rio, Executive Associate Dean Of The Emory School Of Medicine: The President “Has Lost Total Credibility” On Treatments Because Of Hydroxychloroquine.
- “Carlos del Rio, executive associate dean of the Emory School of Medicine, said that it was an exaggeration to call plasma a ‘breakthrough.’ He called plasma an ‘interesting strategy’ and said the data so far was a ‘nice hint’ that it could be helpful, but stressed that it was ‘not going to win the game.’ ‘The problem is, the President, in my mind, has lost total credibility because of what he’s done with hydroxychloroquine. He’s touted so many things that don’t work,’ del Rio said. ‘The reality is what we have today to treat covid is extremely limited.’” [Washington Post, 8/23/20]
Dr. Ashish K. Jha: The “Hyperbole, Mischaracterization Of Evidence” About Convalescent Plasma Is “Very Disappointing.”
- “@US_FDA took big hit to credibility in the manner in which they announced EUA for plasma. To be clear, FDA has the authority & data might even meet the criteria. But manner of role out: hyperbole, mischaracterization of evidence by @SteveFDA very disappointing… Bottom line for EUA is this: if you end up hospitalized, your doctor won’t know if plasma is helpful or not. That’s why we do science And EUA sets us back. Makes it harder to do science right What a week. Some progress. Lots of disappointment.” [Twitter, @ashishkjha, 8/23/20]