In the greatest public health crises in 100 years, we’d expect a responsible and evidence based response to save lives. Yes, mistakes might be made. That’s to be expected in responding to generational events– there can only be so much preparation for them. But the early response was outright inept. Since then the overall response has improved significantly. COVID infected individuals are no longer being sent to live in nursing homes, testing has expanded by magnitudes, and mask wearing is commonplace. But the response is still less than perfect and many of the shortcomings reek of politics.
Let’s start with hydroxychloroquine. After President Trump publicly pushed it in a press conference, the FDA granted Emergency Use Authorization (EUA) for it days later. But there was no credible evidence for it at the time– or even now. At the time, no random control trial (RCT) with a significant sample size had shown or suggested either effectiveness or safety for the drug in patients with COVID-19. In fact, no RCT study had even been attempted at the time on the drug. The FDA eventually pulled the EUA and to this day not only has no RCT study found effectiveness but multiple have found adverse effects. There is no clear justification for the FDAs decision to grant EUA for hydroxychloroquine that doesn’t come back to Trump’s support for it.
This issue again arises with the FDA granting EUA for convalescent plasma in August. Again this comes without any RCT studies showing effectiveness or safety in patients with COVID-19 and after Trump publicly and privately pressured the agency to grant approval. As the New York Times reported:
It was the third week of August, the Republican National Convention was days away, and President Trump was impatient.
White House officials were anxious to showcase a step forward in the battle against the coronavirus: an expansion of the use of blood plasma from recovered patients to treat new ones. For nearly two weeks, however, the National Institutes of Health had held up emergency authorization for the treatment, citing lingering concerns over its effectiveness.
So on Wednesday, Aug. 19, Mr. Trump called Dr. Francis S. Collins, the director of the N.I.H., with a blunt message.
“Get it done by Friday,” he demanded.
It wasn’t done by Friday, and on Sunday, regulators at the Food and Drug Administration still had not finished a last-minute data review intended to ease N.I.H. doubts.
But on Sunday night, the eve of the convention, the president announced, with the F.D.A.’s approval, that plasma therapy would be available for wider use…
Again, there is no clear justification for the FDAs decision to grant EUA for convalescent plasma that doesn’t come back to Trump’s support for it.
Then we have the August change to CDC testing guidelines. At the time there was universal agreement we needed to continue to expand testing, yet the CDC decided to change testing guidelines so that those exposed to someone with COVID-19 but weren’t showing symptoms didn’t need to be tested. There was no possible scientific explanation for why. We know people can be contagious while being asymptomatic. Controlling the pandemic requires identifying those infected so they can be quarantined. But it can– and is– explained by politics. The Times recently reported that the guidelines change “… was not written by C.D.C. scientists and was posted to the agency’s website despite their serious objections…”. This lines up with earlier reporting from CNN. Remember, one of Trump’s favorite talking points is that the reason we have so many cases is because we have so much testing. While false, it is true that the number of reported cases can be lowered with less testing.
Fast forward to this month. CDC director Robert Redfield testified to Congress that the COVID-19 vaccine likely won’t be widely available for general use until mid-2021. This seems obviously true. Even on an optimistic timetable, a vaccine likely won’t complete phase 3 trials until late this year or early next year. After that, it can be distributed to frontline workers and vulnerable populations quickly but it would take time to produce enough doses for everyone and distribute them. Within a few hours Trump publicly tried to undermine Redfield .
Redfield also said that masks “are the most important powerful public health tool we have”.
Again, obviously true. And again, Trump undermined him on this.
Sadly, on the latter issue Redfield seems to be buckling. Watch the full clip of what Redfield said to Congress. Then watch Trump’s response. Then read the tweet below. The change in messaging is clear.
And finally, recently we learned the White House originally planned in April to send five reusable masks to all American residential addresses but scrapped that plan before it was started. The Washington Post reported that the plan was scrapped to help avoid a panic:
“There was concern from some in the White House Domestic Policy Council and the office of the vice president that households receiving masks might create concern or panic,” one administration official said in response to the scrapped mask plan.
But that explanation makes little sense. As Allahpundit wrote: “Panic was already rampant. The country had been locked down for weeks. New York recorded 999 deaths in a single day on April 9. To the extent a supply of free masks would have had any effect on public panic at that point, it probably would have reduced it a bit.” Maybe it was just incompetence but Allahpundit speculated a better explanation:
“It makes no sense to have worried about a national mask giveaway causing panic among the general population in April, when COVID had already hit with full force. But it makes *some* sense, per Trump-logic, to worry about that program causing panic among investors, since free masks for everyone would have suggested that the crisis wouldn’t be over quickly. You don’t undertake to supply 330 million people with some essential good if, as Trump was saying at the time, the country would be getting back to normal by summer. You do something drastic like that if you think you’re staring at a long slog destined to drag the Dow Jones average down over time.”
All of this is important for one reason above all others: when, and if, an eventual vaccine is approved there needs to be public trust in our regulatory institutions to judge that it is safe and effective. In March, almost 70% said they would take the vaccine. Today, that number is only 50%.
That decline reflects a significant decline of public trust in the White House, FDA, and CDC. When leaders in public health roles cower and change their tune to please Trump, Americans lose faith in them. When the heads of the CDC and FDA say a vaccine is safe and effective, Americans need to be able to trust that they are telling the truth– and not that they are bowing to political pressure.
Thankfully pharmaceutical companies are aware of this concern. To try and combat it, nine pharmaceutical companies working on a COVID-19 signed a pledge to not seek FDA approval until phase 3 trials show that their vaccine is safe and effective. Again, from Allahpundit:
Pharma has so little faith in the federal government not to prematurely approve a bum vaccine that’ll potentially be given to 300 million people in order to help Trump’s election chances that they’ve agreed among themselves not to try to jump ahead of each other for competitive advantage. The mercenary capitalists have to protect the public welfare because the government, charged with protecting the public welfare, can’t be trusted to do so when that welfare conflicts with Trump’s electoral hopes.
Optimistically, there is no evidence Trump can approve a vaccine prematurely. Sure, he might try but the safe guard around the approval process is rigorous. The scientists leading the vaccine research and approval processes are icons in the field. For example, Dr. Moncef Slaoui is leading Operation Warp Speed and has been involved in developing vaccines for cervical cancer, Ebola, and malaria. He has publicly said he will resign if he feels political pressure from the White House.
Exit quote: “If he [Trump] were deliberately trying to convince the public not to trust his own health bureaucrats, I don’t know what he’d do differently than what he’s doing.”
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