Advertising
Supported by
Thousands of Covid-19 patients were treated with outdoor blood plasma from rigorous clinical trials, which blocked studies that would have shown if the treatment had worked.
By Katie Thomas and Noah Weiland
An American Airlines flight took off from La Guardia Airport in New York last Wednesday morning, carrying 100 pouches of blood plasma donated by Covid-19 survivors for delivery to Rio de Janeiro. American scientists are hoping Covid-19 patients in Brazil will help them answer a century-old question: Can this golden serum, loaded with antibodies against a pathogen, actually heal the sick?
The truth is that no one knows if it works.
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.
Trials have also been hampered by the disappearance of the virus epidemic in many cities, which has confused the ability of researchers to recruit people with health problems. One such clinical trial, at Columbia University, stopped after the epidemic subsided in New York. One of its leaders, Dr. W. Ian Lipkin, searched for hospitals in other U.S. hotspots. To continue the work. But he discovered few takers.
“Without a randomized controlled trial, it’s very difficult to be sure that what you have is meaningful,” he said.
As of last week, only 67 other people had signed up for the Columbia exam, very few to form sound statistical conclusions. In one last effort, Dr. Lipkin’s team sent the plasma to Brazil, where the epidemic continues.
Now, at the height of a public fitness crisis, the government’s preference to distribute unproven remedies to critical patients as soon as possible may be responsible for conducting clinical trials that could gain advantages for millions of others around the world through finding out if those remedies work.
In a statement, a spokeswoman for the Food and Drug Administration said the expanded access program aimed at closing the hole until trials can begin and “never intended to update randomized clinical trials, which are vitally important in demonstrating effectiveness.”
The F.D.A. is preparing an emergency authorization to use the treatment, according to scientists who have been briefed on the plans. The policy would ease the clerical burden on hospitals to get clearance for transfusions, further hampering clinical trials, researchers said. An F.D.A. spokeswoman declined to comment on whether such an authorization was in the works.
This resolution would mean that the F.D.A. “give in to political pressure,” said Dr. Luciana Borio, who oversaw public readiness for the National Security Council under Trump and the F.D.A.’s interim leading scientist. under President Barack Obama.
“I’m not so involved that political leaders have a flawed technique for science,” he said. “What I consider are scientists who have a flawed technique for science.”
On Monday, four former F.D.A. commissioners — including Dr. Scott Gottlieb, who served under Mr. Trump — called for more rigorous clinical trials to evaluate whether plasma is an effective treatment for the coronavirus. “If this is going to work, we need to do it right,” they wrote.
Convalescent plasma, the pale yellow liquid that’s left after blood is stripped of its red and white cells, has been used since the 1890s to treat infectious diseases, including the flu, SARS and Ebola. Scientists believe it may work by giving sick patients the antibodies of those who have recovered from the infection.
Advertisement