Misstated merit of plasma’s use, FDA chief says
Risk-reduction comments drew criticism from experts
WASHINGTON — Responding to an outcry from medical experts, Food and Drug Administration Commissioner Stephen Hahn on Tuesday clarified his remarks that overstated the lifesaving benefits of treating covid-19 patients with convalescent plasma.
Meanwhile, the number of Americans newly diagnosed with the coronavirus is falling — a development experts say most likely reflects more mask-wearing but also insufficient testing.
Scientists and medical experts have been pushing back against the claims about the plasma treatment since President Donald Trump’s announcement Sunday that the FDA had decided to issue emergency authorization for convalescent plasma, which is taken from patients who have recovered from the coronavirus and is rich in disease-fighting antibodies.
Trump hailed the decision as a breakthrough.
Hahn had echoed Trump in saying that 35 more people out of 100 would survive the coronavirus if they were treated with the plasma. That claim overstated preliminary findings of Mayo Clinic observations.
Hahn’s mea culpa comes at a critical moment for the
FDA — which, under pressure from the White House, is responsible for deciding whether upcoming vaccines are safe and effective in preventing the coronavirus.
The 35% figure drew condemnation from other scientists and some former FDA officials, who called on Hahn to correct the record.
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” Hahn tweeted.
The FDA made the decision based on data the Mayo Clinic collected from hospitals around the country that were using plasma on patients in varying ways — and there was no comparison group of untreated patients, meaning no conclusions can be drawn about overall survival.
People who received plasma with the highest levels of antibodies fared better than those given plasma with fewer antibodies, and those treated sooner after diagnosis fared better than those treated later.
Hahn and other Trump administration officials presented the difference as an absolute survival benefit, rather than a relative difference between two treatment groups.
CLARIFYING THE FINDINGS
“That was not the way that I would have worded it,” said one of the doctors who led the blood plasma study, Arturo Casadevall, chairman of the department of molecular microbiology and immunology at the Johns Hopkins School of Public Health. “I hope they will issue a clarification,” he said Monday.
“Until we have a randomized controlled trial, we don’t know definitively,” Casadevall said.
Robert Califf, the FDA commissioner under former President Barack Obama, said he thought Hahn had misspoken. “It would be good for Steve to publish a correction,” Califf said Monday on Twitter.
The 35% benefit was repeated by Health and Human Services Secretary Alex Azar at Sunday’s briefing and promoted on Twitter by the FDA’s communications staff. The number did not appear in the FDA’s official letter justifying the emergency authorization.
Hahn has been working to bolster confidence in the agency’s scientific process, stating in interviews and articles that the FDA will only approve a vaccine that meets preset standards for safety and efficacy.
Hahn’s predecessor Scott Gottlieb, who served as FDA commissioner under Trump from 2017-19, said he thought the FDA was right to allow convalescent blood plasma for emergency use. But he suggested the news conference hadn’t given the correct picture of what health regulators actually know from the data.
“When we overstate findings it erodes confidence in science and undermines public trust in regulatory decisions. The right message was this ‘may’ provide a benefit, it could be meaningful for some patients, but we need more evidence to prove it,” Gottlieb said in a tweet.
“The way the public part was handled will erode precious public confidence,” he said. “You earn public confidence in small drops and you lose it in buckets.”
SCIENTIFIC DECISION
Hahn pushed back Tuesday morning against suggestions that the plasma announcement was timed to boost Trump ahead of the Republican convention.
“The professionals and the scientists at FDA independently made this decision, and I completely support them,” Hahn said in an appearance on “CBS This Morning.”
Trump has recently accused some FDA staff members of deliberately holding up new treatments “for political reasons.” And Trump’s chief of staff, Mark Meadows, said over the weekend that FDA scientists “need to feel the heat.”
Azar and Hahn both have extensive experience with drugs and therapies. Azar is a former pharmaceutical executive, and Hahn has spent several decades treating patients and researching cancer. Before joining the FDA, he was the chief medical executive of the University of Texas MD Anderson Cancer Center, a leading oncology treatment and research hospital.
In a tweet posted Monday, Hahn said the agency will “reevaluate our emergency use authorization [EUA] based upon new incoming data that we receive.”
He emphasized that the decision to allow emergency use of the therapy had been made based on science alone.
“The data we need, which is a risk-benefit assessment for an emergency use authorization, were met by the data we received,” Hahn said in the CBS interview. But he noted that clinical trials of the therapy, which he expects will provide firmer evidence for or against its use, have had trouble attracting participants — which can happen when patients and doctors can access a therapy through other channels.
“There’s ongoing clinical trials; unfortunately, they’re not accruing like we’d like them to,” Hahn said on CBS.
Blood plasma from recovered patients is being used around the world, with the hope that its infection-fighting antibodies can help combat the virus.
“Based on the data we have today, it’s very likely that plasma is reducing mortality,” Casadevall said.
Convalescent plasma is a century-old approach to treating the flu, measles and other viruses. But the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed.
The FDA emergency authorization is expected to increase its availability to additional hospitals. But more than 70,000 Americans have already received the therapy under the FDA’s “expanded access” program. That program tracks patients’ response but cannot prove whether the plasma played a role in their recovery.
Some scientists worry the broadened FDA access to the treatment will make it harder to complete studies of whether the treatment works. Those studies require randomizing patients to either receive plasma or a dummy infusion.
Convalescent plasma, the pale yellow liquid left over after blood is stripped of its red and white cells, has been the subject of months of enthusiasm from scientists, celebrities and Trump, part of the administration’s push for coronavirus treatments as a stopgap while pharmaceutical companies race to complete dozens of clinical trials for coronavirus vaccines.
ENCOURAGING TREND
Meanwhile, about 43,000 new cases are being reported daily across the country, down 21% from early August, according to data compiled by Johns Hopkins University. While the U.S., India and Brazil still have the highest numbers of new cases in the world, the downward trend is seen as encouraging.
“It’s profoundly hopeful news,” said Dr. Monica Gandhi, an infectious-diseases expert at the University of California, San Francisco, who credits the American public’s growing understanding of how the virus spreads, increasing use of masks and, possibly, an increasing level of immunity.
“Hopefully all those factors are coming into play to get this virus under control in this country that’s really been battered by the pandemic,” she said.
But insufficient testing is probably concealing the full extent of the crisis, said Dr. Jonathan Quick, who leads the pandemic response for the Rockefeller Foundation, which has recommended the U.S. test 4 million people a day by fall.
“We’re grossly undertesting in some of the places that are still having high caseloads,” Quick said, singling out Mississippi, Texas, Georgia and North Dakota as hot spots with high rates of positive test results.
“It’s a good trend, but nowhere near what we need to be,” Quick said of the recent decline.
Jeffrey Shaman, a public health expert at Columbia University, said he is skeptical enough people are immune to significantly slow the spread. But he agreed that changes in Americans’ behavior could be making a difference, recalling the effect that people’s actions had in containing Ebola in West Africa several years ago.
“Ebola stopped for reasons we didn’t anticipate at the time. It was so horrifying that people stopped touching each other,” Shaman said. Something similar may be happening with the coronavirus, he said.
COLLEGE CASES
But many places around the U.S. are seeing pockets of contagion, especially in college towns where students are holding parties and crowding into bars.
Over the past week, 531 students, faculty and staff members at the University of Alabama in Tuscaloosa have tested positive for the virus, according to the school. Alabama said it tested nearly 30,000 students before classes began. The mayor of Tuscaloosa shut down bars for two weeks because of the spike, which could derail plans to continue the semester on campus.
The university is still moving ahead with fall sports in the football-crazed state, with plans to allow only about 20,000 fans at its 101,000-capacity stadium and a ban on tailgating. Coach Nick Saban weighed in on the virus Monday, urging people to wear masks.
“It’s not just about football. So for people to make the right choices and decisions to wear their masks, do the things when they’re out publicly, respect the rules, respect the virus, that’s important,” he said.
Officials at the University of Tennessee at Knoxville said four students are facing disciplinary proceedings after three hosted off-campus parties with no masks or distancing and another left isolation to meet with others despite testing positive for the virus.
“If the facts reported to the university are accurate, these students will face at least suspension from the university, and potentially greater penalties,” Chancellor Donde Plowman wrote.
NURSING HOME STAFFS
Separately, the Trump administration announced Tuesday that it will require nursing home facilities to test staff members regularly or face fines.
The move comes months after the White House first urged governors to test all nursing home residents and staffs. With regard to residents, nursing homes are being required to offer them coronavirus tests if there is an outbreak or if any show symptoms.
Long-term care facilities represent less than 1% of the U.S. population, but they account for 42% of the covid-19 deaths, with more than 70,000 fatalities reported by the COVID Tracking Project.
“Our recommendations for testing in nursing homes go back as far back as March and April,” said Seema Verma, head of the Centers for Medicare and Medicaid Services. “What’s different about today is that this is now a requirement. … We want to make sure every single nursing home is complying.”
Independent research indicates that the coronavirus most likely gets into nursing homes via staffers who unwittingly carry it in from surrounding communities where it has started to spread. Staffers who have yet to develop symptoms may have no clue that they’re infected.
The government will provide $2.5 billion to help nursing homes with testing costs, Verma also announced. The administration’s campaign to distribute fast-test machines and an initial supply of tests is supposed to be done by the end of September.
The nursing home industry said it supports mandatory testing as long as facilities are given what they need to comply with requirements.
Information for this article was contributed by Matthew Perrone, Deb Riechmann, Lauran Neergaard, Carla K. Johnson, Ricardo Alonso-Zaldivar and Adam Geller of The Associated Press; by Drew Armstrong and Michelle Fay Cortez of Bloomberg News; and by Katie Thomas and Sheri Fink of The New York Times.