Will Trump Pressure the FDA to Approve a Covid-19 Vaccine …

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 Americas failed response to the pandemic, along with Trump.

Trumps 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 cant be on the Trump administration, which has an election to win.

Trump and Navarros 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 Trumps 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 plasmas 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 Childrens Hospital of Philadelphia and a member of the FDAs 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 Baylors College of Tropical Medicine, told Rolling Stone. Theyre really good scientists trying to think through this, so I dont think theyre going to be swayed. But who knows whats going to happen.

What could happen, though, is that the good scientists will just resign. On Friday, Peter Marks, director of the FDAs 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 thats my red line. I would feel obligated [to resign] because in doing so, I would indicate to the American public that theres something wrong.

Marks initially threatened to resign during a recent call between government officials, pharmaceutical executives, and members of the NIHs 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 hed 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. Its not going to be easy, he said. Its 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. Its doable, but its not going to be easy.

The president might not see that timeline working for him.

Read more from the original source:

Will Trump Pressure the FDA to Approve a Covid-19 Vaccine ...