FDA’s Authorization Of Convalescent Plasma Launches Torrent Of Questions
Does it really work? Is the move politically motivated? Dr. Stephen Hahn, head of the FDA, defended his agency against the second charge, while global scientific experts raise concerns about the first.
The Hill:
FDA Chief Says Criticism For Misrepresenting Convalescent Plasma Stats Is Warranted
The head of the Food and Drug Administration (FDA) on Monday said criticism for his praise of convalescent plasma treatment was warranted, but denied the decision to authorize the emergency use of the treatment for COVID-19 patients was politically motivated. "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," Stephen Hahn said in a lengthy Twitter post. (Weixel, 8/24)
CNN:
Trump's Aggressive Stance On Virus Treatments Raises Concerns About Putting Politics Ahead Of Safety
As President Donald Trump races to reassure Americans that good news is on the way before the November election, there are concerns that efforts to fast-track coronavirus therapeutics and a vaccine are putting politics before health and safety. Trump is set to lay out his vision for four more years amid a global pandemic and staggering unemployment at the Republican National Convention starting Monday -- and key to that vision will be overcoming the spread of coronavirus. (Klein, 8/24)
Boston Globe:
FDA’s Plasma Decision May Hamper ‘Gold Standard’ Research, Experts Say
The FDA’s decision this week to allow convalescent plasma as a treatment for COVID-19 will make it harder to conduct rigorous studies of its effectiveness, because patients will demand the therapy rather than agreeing to studies in which they might get a placebo, experts said Monday. The “emergency use authorization” issued by the Food and Drug Administration on Sunday allows doctors to infuse COVID-19 patients with plasma from people who have recovered, even if the treatment is not part of a study. The theory is that the recovered person’s antibodies can help a sick person fight off the illness. (Freyer, 8/24)
NBC News:
Why Did The FDA Authorize Convalescent Plasma, A Potential Treatment For COVID-19?
The Trump administration's announcement Sunday of an emergency use authorization for convalescent plasma left critical questions about the potential COVID-19 treatment unanswered. Which patients will benefit? When should doctors administer the plasma? What is the correct dosage? And perhaps most crucial: Does it even work? (Edwards, 8/24)
AP:
UN Cautions That Virus Plasma Treatment Still Experimental
The World Health Organization on Monday cautioned that using blood plasma from COVID-19 survivors to treat other patients is still considered an experimental therapy, voicing the concern as a U.S. boost for the treatment has many scientists afraid formal studies will be derailed. On Sunday, the U.S. Food and Drug Administration authorized what’s called “emergency use” of the treatment under its special powers to speed the availability of promising experimental drugs during a public health crisis. The action isn’t the same as approving plasma as safe and effective, and numerous rigorous studies are underway to find out if it really works. (Cheng, 8/25)
The Hill:
Science Inconclusive On Use Of Convalescent Plasma In COVID-19 Patients
President Trump’s announcement that his administration would approve the emergency use of convalescent plasma in patients suffering from COVID-19 has put the government out of step with scientists who say there is no firm indication yet that such treatment actually works. The Food and Drug Administration (FDA) late Sunday issued an emergency use authorization for convalescent plasma, allowing it to be administered to those hospitalized with COVID-19. In a letter, FDA chief scientist Denise Hinton said the agency had concluded “that it is reasonable to believe that COVID-19 convalescent plasma may be effective for the treatment” of those in the hospital. (Wilson, 8/24)
The New York Times:
F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say
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. ... 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. (Thomas and Fink, 8/24)
The Washington Post:
Administration Claims On Effectiveness Of Convalescent Plasma Wrong, Misleading, Scientists Say
The assertion was breathtaking: Out of 100 people who suffered from the illness caused by the novel coronavirus, 35 were saved by the injection of antibody-rich plasma from people who had survived the disease. That’s how Food and Drug Administration Commissioner Stephen Hahn described the blood product’s effectiveness on Sunday at a news conference at the White House. ... But the 35-out-of-100 claim wasn’t accurate, scientists said Monday. The FDA commissioner appeared to have mixed up absolute risk and relative risk, which are basic concepts in economics and in the presentation of data from clinical trials. “I’m absolutely incredulous,” said Peter Lurie, a former top FDA official and now the president of the Center for Science in the Public Interest. (McGinley, Abutaleb and Bernstein, 8/24)
Politico:
Navarro’s Push For Plasma Treatment Goes Further Than FDA Scientists
White House trade adviser Peter Navarro on Monday exaggerated the efficacy of blood plasma as a coronavirus treatment, urging Americans to disregard any skepticism of the controversial therapy. The remarks from Navarro — who has previously promoted dubious coronavirus treatments, including hydroxychloroquine — came after the Food and Drug Administration on Sunday issued an emergency use authorization for convalescent plasma to treat Covid-19 patients. (Forgey, 8/24)
