Trump Goes Viral, Con't

Trump's latest stunt ahead of his four-day infomercial from hell is announcing a NeW BrEAkThROuGh tREaTmeNT for the coronavirus, which apparently is news to both the entire medical science community and to the coronavirus.

The Food and Drug Administration issued an emergency authorization for blood plasma as a coronavirus treatment, the agency and President Donald Trump announced Sunday — one day Trump attacked the drug regulator for moving too slowly to back the treatment.

The agency held off on the decision last week over concerns from government scientists that evidence for the treatment's effectiveness is thin, prompting Trump to accuse the FDA of slow-walking the therapy to harm his reelection chances without offering any evidence to support his claim. It is not clear whether the FDA has received additional clinical trial data in the last week that would support the therapy's use.

An emergency authorization normally paves the way for expanded use of an experimental therapy. But FDA's decision for so-called convalescent plasma — which more than 70,000 Americans have already received — is limited because patients have largely received it outside of randomized, controlled clinical trials that could prove whether the approach is effective.

Trump in a brief Sunday evening news conference appeared to oversell the FDA's assessment, claiming the agency found plasma "safe and very effective." However, the agency said more rigorous study is needed to prove whether the treatment effective. Janet Woodcock, the head of FDA's drug division who is now working on Operation Warp Speed, an interagency effort to accelerate coronavirus treatments and vaccines, on Friday told POLITICO that plasma has not been "proven as an effective treatment."

And unlike Gilead's remdesivir, which received an emergency use authorization months ago and has shown to benefit hospitalized patients, convalescent plasma "does not yet represent a new standard of care based on the current available evidence," FDA said in a statement.

Trump announced the emergency authorization alongside his health secretary, Alex Azar, and FDA Commissioner Stephen Hahn, in a press conference one day before the start of the Republican National Convention. While Trump called it a "historic announcement," experts have said the treatment is unlikely to be a game-changer in the fight against a pathogen that's killed more than 170,000 in the United States.

Hahn, who took over as FDA chief in December, said Trump "has asked FDA to cut back red tape and try to speed medical products into the hands of providers, patients and American consumers."

Outside experts and former officials have accused FDA of caving to White House pressure during the pandemic -- most notably in its decision to authorize emergency use of hydroxychloroquine for treating Covid-19 infection despite limited evidence. The agency later pulled the authorization after randomized clinical trials found it provided no benefit, but Trump as recently as this weekend complained about the agency's reversal.

Plasma therapy involves giving the sick antibody-rich plasma extracted from the blood of coronavirus survivors. In theory those antibodies should help recipients fight off the virus. But while plasma treatment has been used safely against diseases from diphtheria to Ebola over the past 130 years, its track record on effectiveness is mixed. And it has not yet been proven to work against the coronavirus.

Scott Gottlieb, Trump's first FDA commissioner, on Sunday said that plasma is "probably beneficial" for coronavirus patients, as he also acknowledged scientists' concerns about the lack of evidence for the treatment.

"I think some people wanted to see more rigorous data to ground that decision," Gottlieb said on CBS's "Face the Nation."

So this is now what, the third? Fourth? Fifth "treatment breakthrough" announced by the FDA, none of which actually have been confirmed by the FDA or backed up by doctors in other countries for that matter. None of them are actually treatment breakthroughs, and none of them are even remotely ready for widespread use yet (remember, if remdesivir from pharma giant Gilead was working as well as thought, why not make that available for widespread use?)

At least the American media isn't taking Trump seriously or giving him the benefit of the doubt when he's clearly forcing the FDA to move up the timetable for political reasons ahead of the Republican convention this week.

The sad part is 175,000 Americans have died to this virus, and Trump is the most upset about how it's hurting his poll numbers. He doesn't care if your loved ones die to the virus or not, he just cares if he wins.

But what Trump will almost certainly do is announce an October Surprise vaccine that doesn't have rigorous testing behind it, and that will be the nightmare scenario from a public health standpoint.

The Trump administration is considering whether to bypass normal U.S. regulatory standards to fast-track an experimental coronavirus vaccine from the U.K. for use in America ahead of the presidential election, the Financial Times reported, citing three unnamed people briefed on the plan.

One option is to issue an “emergency use authorization” in October to a vaccine being developed by AstraZeneca Plc and Oxford University, based on the results from a relatively small U.K. study if it is successful, the people told the British newspaper.

A spokesman for the U.S. Health and Human Services department, which oversees the Food and Drug Administration, told the Financial Times that any claim that an EUA would be issued before the election was “absolutely false.” The administration was hopeful that a vaccine would be developed by the first quarter of 2021, he said.

With Covid-19 infections still widespread in the U.S., President Donald Trump’s political future hinges on his response to the pandemic and his promise to bring forth a vaccine by Election Day on Nov. 3. On Saturday, he tweeted that employees at the FDA are attempting to sabotage his re-election by slowing down coronavirus research.

There’s no evidence that the scientists and staff of the FDA are delaying treatments or vaccines.

The FT article came shortly before Bloomberg reported that the president is set to announce that a new treatment involving blood plasma donated by people who’ve recovered from the disease has received an emergency use authorization from U.S. regulators.

Mark Meadows, White House chief of staff, and Steven Mnuchin, Treasury secretary, have told top Democrats that the administration was considering fast-tracking a vaccine, the Financial Times reported. A spokesperson for the Treasury secretary said in response that Mnuchin “did not make any comments regarding AstraZeneca” and believes any decision on vaccine candidates is up to the FDA.

A spokesperson for AstraZeneca told the Financial Times that it had “not discussed emergency use authorization with the U.S. government” and that it “would be premature to speculate on that possibility.” AstraZeneca’s trial of 10,000 participants may be too small to justify just an order, according to the newspaper.

Trump will have to have a "vaccine" before the election, or there is zero chance he wins. And how many of his cultists will line up to take it because Trump said so?