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As Trump Praises Plasma, Researchers Struggle to Finish Critical Studies
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As Trump Praises Plasma, Researchers Struggle to Finish Critical Studies
Tue, 2020-08-04 19:31 — mike kraftSince April, the Trump administration has funneled $48 million into a program with the Mayo Clinic, allowing more than 53,000 Covid-19 patients to get plasma infusions. Doctors and hospitals desperate to save the sickest patients have been eager to try a therapy that is safe and might work. Tens of thousands more people are now enrolled to get the treatment that’s been trumpeted by everyone from the president to the actor Dwayne Johnson, better known as The Rock.
President Trump on Monday promoted its promise: “You had something very special. You had something that knocked it out. So we want to be able to use it,” he said, calling on Covid-19 survivors to donate their plasma, which he called a “beautiful ingredient.”
But the unexpected demand for plasma has inadvertently undercut the research that could prove that it works. The only way to get convincing evidence is with a clinical trial that compares outcomes for patients who are randomly assigned to get the treatment with those who are given a placebo. Many patients and their doctors — knowing they could get the treatment under the government program — have been unwilling to join clinical trials that might provide them with a placebo instead of the plasma.
The trials have also been stymied by the waning of the virus outbreak in many cities, complicating researchers’ ability to recruit sick people. One of those clinical trials, at Columbia University, sputtered to a halt after the outbreak subsided in New York. One of its leaders, Dr. W. Ian Lipkin, looked for hospitals in other hot spots in the United States to continue the work. But he found few takers.
“Without a randomized control trial, it’s very difficult to be certain that what you have is meaningful,” he said.
As of last week, just 67 people had enrolled in the Columbia study — too few to form sound statistical conclusions. In a last-ditch effort, Dr. Lipkin’s team shipped the plasma to Brazil, where the epidemic is still raging.
Now, at the height of a public health crisis, the government’s push to distribute an unproven treatment to desperately ill patients as quickly as possible could come at the cost of completing clinical trials that would potentially benefit millions around the world by determining whether those treatments actually work....
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