Public health experts on Saturday decried the Food and Drug Administration’s “troubling” approval of a Covid-19 treatment which has not been proven to help patients who are severely ill with the disease.
The FDA expanded its emergency authorization on remdesivir on Friday evening, allowing its use for all patients who are hospitalized with Covid-19. Previously, the drug had been approved—and shown to benefit—only patients who are not ill enough to require the use of a ventilator.
FDA Commissioner Stephen Hahn claimed that “the data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus,” but epidemiologists and other experts pushed back.
“No published research supports such widespread use,” tweeted Eric Fiegl-Ding, a fellow at the Federation of American Scientists.
Remdesivir has been shown to improve recovery time for patients who require oxygen but not ventilation, but has not been shown to save lives in the sickest patients, according to data from the New England Journal of Medicine.
“It seems to be a pattern of approval without science, without data, without evidence,” Eric Topol, vice president for research at Scripps Research in La Jolla, California, told USA Today.
Earlier this week, Topol expressed “horror” at claims made by Hahn and President Donald Trump about the efficacy of convalescent plasma in treating the coronavirus. Hahn later apologized publicly for overstating the benefits of plasma from patients who have recovered from Covid-19.
On Friday, two public relations officials were fired from their jobs at the FDA. Both had been involved in the agency’s messaging regarding plasma, and one had encouraged Hahn to apologize for his original statement about the treatment. The dismissals, as well as Trump’s repeated claims that the agency is standing in the way of his reelection chances by holding back approval for treatments and vaccines, raised alarm among public health experts who fear the politicization of the FDA in the midst of the Covid-19 pandemic.
For many members of the public, Topol told USA Today, the FDA’s credibility has “already been sacrificed.”
As Common Dreams reported earlier this week, the White House has recently suggested that a vaccine for Covid-19 could be approved by the FDA as early as September. The Trump campaign reportedly refers privately to a vaccine approval by October, just ahead of the general election, as “the holy grail.”
“I hope Stephen Hahn will find his conscience and think about the greater good and greater harm his agency can cause,” tweeted Feigl-Ding on Saturday. “Bending to Trump White House pressure will only harm trust in the longtime venerable institution and hurt public health for generations to come.”
Lindsey Graham announces embattled Sen. Joni Ernst will vote for whomever Trump nominates to replace RBG
The chairman of the Senate Judiciary Committee on Monday announced that GOP members of the body would be united in voting for whomever President Donald Trump nominates to replace Ruth Bader Ginsburg on the U.S. Supreme Court.
“The nominee’s going to be supported by every Republican in the Judiciary Committee," Sen. Lindsey Graham (R-SC) said, as reported by The Washington Post's Aaron Blake.
If Graham is correct, that would mean that Sen. Joni Ernst (R-IA) would be backing the nomination, despite trailing Democratic challenger Theresa Greenfield.
A Never-Trump Republican changed her mind — then crumbled when she tried to explain why
In a recent op-ed for the Washington Post, Republican Danielle Pletka declared that despite the fact that she refused to vote for Donald Trump in 2016, she now feels compelled to support him in 2020. The piece quickly caught fire online, inspiring ridicule and sympathy from differing corners and triggering a surprising amount of discussion.
In one sense, it’s hard to see what the big deal was. The Post publishes opinion pieces in support of Trump frequently, and this one was not particularly special. Pletka herself is not a particularly notable figure. Like many op-eds, it was sloppy and unpersuasive, making huge leaps of reasoning and glossing over critical points in the argument. It didn’t take seriously any compelling counterarguments. It was, in other words, a mere display of partisan loyalty from a Republican who would prefer to be inside the tent than outside of it.
Here’s the doomsday scenario in Pennsylvania that could cost Joe Biden the election
On Monday, the Philadelphia Inquirer walked through a potential voter error that could cost Joe Biden Pennsylvania — the exclusion of so-called "naked ballots," or mail-in ballots that aren't properly sealed in two layers of envelopes.
"The state Supreme Court in Pennsylvania, a critical battleground state that’s seen as increasingly likely to determine who wins the White House, last week ordered officials to throw out 'naked ballots' — mail ballots that arrive without inner 'secrecy envelopes,'" reported Jonathan Lai. "Pennsylvania uses a two-envelope mail ballot system: A completed ballot goes into a 'secrecy envelope' that has no identifying information, and then into a larger mailing envelope that the voter signs."