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As Trump Praises Plasma, Researchers Struggle to Finish Critical Studies

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Since 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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Mark McClellan, Margaret Hamburg, Robert Califf and Scott Gottlieb are former commissioners of the Food and Drug Administration.

President Trump last week called on those who have recovered from covid-19 to donate their blood plasma as a potential treatment for help stem the pandemic. More work has yet to be done to demonstrate that such a therapy is safe and effective, but if so, it could help millions of patients with the novel coronavirus both here and abroad.

 

The United States could desperately use such a treatment. The nation continues to struggle with high rates of hospitalizations and tragic deaths. While vaccine development continues, it’s important to advance every promising treatment option to improve the odds for those who become sick.

Blood plasma — also known as convalescent plasma — has been used as a therapy for infectious diseases for a century, including against the flu in 1918 as well as SARS, Ebola, meningitis and measles. While it doesn’t work for all infections, the idea is to use one person’s successful defense system of antibodies to bolster the immune response of a newly infected person.

The United States has been the leading global supplier of plasma products. Now, we’re also the world’s leading supplier of coronavirus cases, with around 60,000 a day. If convalescent plasma does help, it could help mitigate the impact of the pandemic.

But if this is going to work, we need to do it right. We need a concerted effort to collect blood plasma, along with clinical trials to determine when its benefits outweigh the risks so we can treat the right people at the right time. With that evidence in hand, we need to maintain a highly synchronized distribution system to get the plasma to the right health-care facilities in a timely and equitable way....

 

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