Will Trump Pressure the FDA to Approve a Covid-19 Vaccine? - Rolling Stone
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Will Trump Pressure the FDA to Approve an Unsafe Covid-19 Vaccine?

The Food and Drug Administration authorized use of plasma to treat coronavirus patients — after the president alleged the “deep state, or whoever” is holding up Covid-19 treatments

WASHINGTON, DC - AUGUST 23: FDA Commissioner Stephen Hahn looks on as President Donald Trump announces that the Food and Drug Administration is issuing an emergency authorization for blood plasma as a coronavirus treatment during a press conference in James S. Brady Briefing Room at the White House on on August 23, 2020 in Washington, DC. The move by the FDA comes after President Trump accused the FDA of slow-walking the therapy to harm his reelection chances.(Photo by Pete Marovich/Getty Images)

FDA Commissioner Stephen Hahn looks on as President Trump announces that the FDA is issuing an emergency authorization for blood plasma as a coronavirus treatment, on August 23rd, 2020.

Pete Marovich/Getty Images

On Saturday, President Donald Trump fired off one of his most deranged, conspiratorial, and flat-out terrifying tweets since he took office — which at this point is really saying something.

“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” he wrote. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”

In other words, Trump is claiming there are anti-Trump forces in the Food and Drug Administration who are deliberately hamstringing efforts to develop a Covid-19 vaccine in order to hurt his re-election chances. Trump wrote that this is “obviously” the case, tagging FDA Commissioner Stephen Hahn, whom Rolling Stone dubbed one of the four men responsible for America’s failed response to the pandemic, along with Trump.

Trump’s tweet came five days after his trade adviser, Peter Navarro, reportedly accused FDA officials to their faces of being part of the “Deep State,” telling them they need to “get on Trump Time” in facilitating a cure for the novel, once-in-a-generation virus that has now killed over 175,000 Americans. The blame has to fall somewhere, and of course it can’t be on the Trump administration, which has an election to win.

Trump and Navarro’s frustration stems from both the lack of a vaccine — which typically take years, not months, to develop — and the lack of approved therapeutics to treat the virus. After the FDA last week put a hold on granting emergency-use authorization for using blood plasma from people who have recovered from Covid-19 to treat the virus, Trump told reporters it “could be a political decision.” After alleging on Saturday that the agency is run by the “Deep State,” Trump criticized its decision in June to revoke the emergency-use authorization for hydroxychloroquine, a drug Trump and Navarro championed and which the FDA ultimately deemed an ineffective Covid-19 therapeutic.

As fate would have it, a day after Trump’s critical tweets the FDA issued an emergency-use authorization for using blood plasma to treat Covid-19. The decision was made despite objections from government scientists at the National Institute of Health, including Dr. Anthony Fauci, who argued that the data on plasma’s effectiveness was insufficient. The pressure from the Trump administration apparently carried a little more weight. “We broke the logjam over the last week,” Trump said during a press briefing on Sunday. “I think there are people in the FDA and actually in your larger department that can see things being held up.”

The potential for the FDA to cow to pressure from Trump has been a concern since the race to develop a vaccine began. The concern is swelling now that the president is trailing in the 2020 election polls and desperate for a win — such as, say, headlines about a vaccine breakthrough. Unfortunately, “Trump Time,” as Navarro puts it, has no real concern for the opinion of scientists, or for the fact that it typically takes years if not decades to develop a safe and effective vaccine. Rushing the approval of a Covid-19 inoculation, or therapeutics, that could be administered to tens of millions could lead to a public-health catastrophe on top of the existing public-health catastrophe.

“Although we see regulation as burdensome, you want the FDA to regulate these products,” Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a member of the FDA’s vaccine advisory committee, told Rolling Stone in May. “You want someone to take a long hard look at what the data are before they license it for use in this country.”

“There was a moment when Donald Trump said the FDA was working with them,” Offit said. “That worries me.”

Others took comfort in the integrity of the scientists staffed at the Food and Drug Administration. FDA employees “tend to insulate themselves pretty well from all the hype, and they tend to look at things without bias,” Dr. Peter Hotez, dean of Baylor’s College of Tropical Medicine, told Rolling Stone. “They’re really good scientists trying to think through this, so I don’t think they’re going to be swayed. But who knows what’s going to happen.”

What could happen, though, is that the “good scientists” will just resign. On Friday, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told Reuters he would step down if the Trump administration forces the approval of a vaccine that has yet to be proven safe and effective. “I could not stand by and see something that was unsafe or ineffective that was being put through, he said. “You have to decide where your red line is, and that’s my red line. I would feel obligated [to resign] because in doing so, I would indicate to the American public that there’s something wrong.”

Marks initially threatened to resign during a recent call between government officials, pharmaceutical executives, and members of the NIH’s working group on vaccines. Concern was reportedly expressed about an “October surprise” in which the Trump administration would rush to announce a vaccine candidate right before the election, prompting Marks to say he’d step down if this happened.

Although Trump has said on multiple occasions that a vaccine could be ready by the election, this is unlikely, if not impossible. Hotez told Rolling Stone that late 2021 or early 2022 is the best-case scenario. “It’s not going to be easy,” he said. “It’s going to have to be a very carefully orchestrated dance between the epidemiological models, the scientists, the business community, and government leaders to work this out. It’s doable, but it’s not going to be easy.”

The president might not see that timeline working for him.


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