Healthcare

NIH panel: 'Insufficient data' to show treatment touted by Trump works

NIH panel: 'Insufficient data' to show treatment touted by Trump works

A panel of experts convened by the National Institutes of Health (NIH) said Tuesday that there is no evidence yet that a treatment for coronavirus touted by President TrumpDonald TrumpTrump PACs brought in over M for the first half of 2021 Chicago owes Trump M tax refund, state's attorney mounts legal challenge Biden hits resistance from unions on vaccine requirement MORE works. 

The treatment in question, known as convalescent plasma, was issued in an Emergency Use Authorization by the Food and Drug Administration (FDA) in August, a move highlighted by Trump at a White House press conference.   

On Tuesday, though, the COVID-19 Treatment Guidelines Panel at the NIH said in a statement that “there are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19.” 

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“Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19,” the statement added. 

The statement takes a sharply different tone than Trump, who touted the treatment as a “historic breakthrough” in fighting coronavirus at the White House last month. He added that the treatment has had “an incredible rate of success.”

Convalescent plasma treatment uses antibodies from the blood of people who have recovered from coronavirus to help treat others. 

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The NIH panel is not saying definitively that the treatment will not work, but it is saying that randomized clinical trials, the scientific gold standard, are needed to determine its effectiveness.

The FDA issued its emergency authorization based on a less powerful kind of study, where some people with higher doses of the treatment had an improvement over some with lower doses, but without a control group of people who did not get the treatment at all for comparison. 

NIH Director Francis Collins later downplayed the statement, saying it echoed conclusions that the FDA had already made in its Emergency Use Authorization.

"Surprised by media uproar on Treatment Guidelines on convalescent plasma for #COVID19," Collins tweeted. "Guidelines mirror EUA: possible benefit, seems safe, randomized trials needed....No news here."

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The NIH's conclusion comes as health experts have raised concerns over an array of examples of what they fear are politically-motivated moves by health agencies responding to pressure from Trump. 

The New York Times reported last month that top NIH officials raised concerns that there was not enough data for an emergency use authorization from the FDA. 

The FDA issued the authorization under pressure from Trump who had recently railed against the “deep state” at the agency, though Commissioner Stephen HahnStephen HahnTrump discussed sending infected Americans to Guantanamo Bay: book Stephen Hahn joining venture capital firm behind Moderna Redfield says Azar pressured him to revise COVID-19 data reports MORE denied that political pressure was a factor in the decision. 

Beyond the convalescent plasma authorization, health experts point to the FDA’s authorization of hydroxychloroquine, another Trump-touted treatment, where the authorization was later revoked.  

The Centers for Disease Control and Prevention also came under fire for new guidelines saying asymptomatic people do not need to be tested. 

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On convalescent plasma, randomized clinical trials have begun, but are having trouble enrolling participants given that the treatment is already available outside of a trial, harming the ability to study it further. 

In fact, thousands of people got the treatment even before the FDA emergency authorization through a separate program. 

This story was updated at 9:51 a.m.