NC Senate Dem candidate: I'd be hesitant to get a COVID vaccine approved by Trump's FDA

A bad vaccine answer by a prominent Democrat, and not for the first time lately.

But it’s not as bad as I wish it were.

First, watch the clip:

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There are two separate but intertwined questions here:

1. Is Trump’s FDA trustworthy?
2. Should I let the answer to the first question guide my decision on whether to get the vaccine?

The answer to both questions is no. On whether or not to trust the FDA, I’m tempted to simply direct you to this piece by David Gorski of Science-Based Medicine describing the numerous examples of Trump and his cronies trying to politicize COVID research at the FDA and CDC this year — with some success. It’d be one thing if there were a heroic resistance at both agencies to having their findings steered by politics, but Gorski notes how the FDA initially approved hydroxychloroquine and later convalescent plasma for emergency use with zero evidence from randomized clinical trials that they’re effective against COVID. (The emergency-use authorization for hydroxychloroquine was later rescinded.) In years past, Gorski writes, if you’d asked him whether we should trust the FDA he’d have answered “yes” emphatically. Now he doesn’t know anymore.

Here’s a charming anecdote from the Times about how convalescent plasma eventually gained the FDA’s seal of approval:

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.

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They ended up getting it done by the following Sunday, after the boss published this banana-republic tweet to pressure them. As is so often true with Trump, the corruption happens out in the open:

https://twitter.com/realDonaldTrump/status/1297138862108663808

At that Sunday press conference, FDA chief Stephen Hahn overstated the measurable benefits of plasma from one study so wildly that he had to apologize for his mistake eventually on Twitter. The jury remains out on whether the head of the FDA is scientifically illiterate or just a hack who tried to oversell the president’s new wonder drug to the public deliberately:

[Bill Gates] leveled his harshest criticism at Food and Drug Administration Commissioner Stephen Hahn, who mischaracterized findings from a Mayo Clinic study on Covid-19 and said researchers had seen a 35% survival benefit with the use of convalescent plasma. “Many of you know I was a cancer doctor before I became FDA commissioner,” Hahn said at the time. “And a 35% improvement in survival is a pretty substantial clinical benefit.”

“This is third grade math. I mean, are you kidding?” Gates said. “The head of the FDA got up and said it was a 35% death reduction where it’s not even a 3% reduction based on just a tiny little subset that was nonstatistical. This is unheard of.”

In fact, there are no data from randomized controlled trials to indicate whether convalescent plasma — an antibody rich blood product created from blood donations from Covid-19 survivors — actually increases survival.

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If it were just the FDA that had been politicized, that would be bad enough. But there’s been a series of reports over the past week about the lengths to which Trump crony Michael Caputo and his “science advisor” have gone to try to strong-arm the CDC into shaping its conclusions about COVID to better suit Trump’s sanguine message about the virus. At last check, Caputo was seen ranting on Facebook about “sedition” by the CDC and warning about possible plots to kill him. No wonder Gorski and Gates have lost faith in that agency as well:

Likewise, Gates could not believe the administration’s recent move to rewrite CDC testing guidance to state that people who weren’t displaying symptoms didn’t need to be tested. Experts said the revised recommendations will make it harder to find and isolate people who are just becoming infectious — undermining efforts to limit spread of the virus. “It blows the mind,” Gates said.

The new advice reportedly had the support of Scott Atlas, a recent addition to the White House coronavirus task force. Atlas, a neuroradiologist and a public policy fellow at Stanford University’s Hoover Institution, has reportedly been advocating a policy of allowing the virus to spread unchecked so the country can reach herd immunity quicker.

Gates is not a fan. “The administration’s now hired this Stanford guy who has no background at all just because he agrees with their crackpot theories.”

Correct. The response to all this will be that it’s “irresponsible” to warn people ahead of the vaccine’s rollout that the federal government’s health bureaucracy has been too corrupted by politics to be trusted. I’d say it’s irresponsible not to warn them. Most don’t even need warning, in fact. They follow the news. They’ve sized up the president’s credibility. They know the score: “Fifty-two percent of adults say they don’t trust the president’s vaccine comments, while just 26 percent say they do,” according to a new NBC poll. If people are having trouble trusting the FDA, take it up with the clown who accused the agency on Twitter of having been infiltrated by the “deep state.”

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But.

The fact that Trump and his corrupt cronies can’t be trusted doesn’t mean that AstraZeneca and Oxford and Moderna and BioNTech and the researchers at the University of Pittsburgh and a galaxy of other well-meaning scientists working hard to end this nightmare shouldn’t be. (Yes, really, Big Pharma is the trustworthy actor in our modern dystopia.) It was less than a week ago that Oxford and AstraZeneca paused their UK vaccine trial involving tens of thousands of subjects because a single person had developed a health issue that raised concern. Any company that emerges with a viable vaccine candidate will publish its findings knowing that that data will be closely scrutinized by thousands of independent experts around the world. Their verdicts will appear in big media and social media. If there are red flags in the research suggesting a safety issue, we’ll hear about it. Loudly. There’ll be no mystery about whether the “winning” vaccine is or isn’t risky.

The drug companies working on vaccines are so nervous about perceptions of the Trump administration’s corruption spoiling the public’s reception to their own product that they signed a pledge last week not to even seek FDA authorization until they’ve proved their products are safe and effective following Phase 3 trials. Think about that. 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.

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Democrats have to get better on capturing the nuances of all this. The answer when asked whether you’ll get the vaccine isn’t “I’m hesitant because I don’t trust Trump.” That’s going to set back the effort to get the population immunized, which is already a heavy lift thanks to a witch’s brew of hyperpartisanship, anti-vax kookery, and Trump’s immolation of the government’s credibility. The correct answer about whether to get the vaccine is “I’m going to watch what independent experts say, and if they’re excited about the data then I’ll be first in line.” Take Trump and the FDA completely out of the equation. No one should trust them, but no one needs to in an age of mass media when we’re inundated with opinion. Every expert with a view on the new vaccine’s safety and efficacy will find an outlet to air that opinion. A consensus will be apparent soon enough.

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