The story of convalescent plasma is one of a federal medical establishment wanting badly to compensate for its slow response to the coronavirus.
WASHINGTON — Jimmy Glenn, a one-time boxing instructor, opened his Times Square bar in 1971. The grandson of Southern sharecroppers, Glenn would keep his bar open through years of crime and grime, urban flight and terror fears. He kept it open right until mid-March, when New York Gov. Andrew Cuomo announced that all eating and drinking establishments in the state had to close because of the coronavirus pandemic.
Recovering from an infectious disease usually leaves a patient with plenty of armaments, known as antibodies, against the infection. Those antibodies can be collected in the form of convalescent plasma and transferred to someone still battling the same infection, potentially providing the crucial boost the recipient needs to recover.
To be sure, the FDA is relying on sound, decades-old science in advocating for the use of antibodies as a treatment. And the agency is, at the same time, supporting the kind of randomized clinical trials that will in the not-too-distant future yield definitive answers about how convalescent plasma should be used. That will take time, however.
"I went through a very long battle with the hospital,” Adam Glenn recalls. Doctors at NYU Langone were hesitant to use the Mayo Clinic protocol, but Glenn kept pushing, and they finally relented. “We have no efficacy data at this time,” acknowledged a spokesperson for the Mayo Clinic, which received $26 million from the federal government to administer the expanded access program.
That, at least, is the thinking behind the Mayo Clinic program. “I have never seen a blood product up and going as quickly as this one has,” says Cliff Neumark, a vice president at Vitalant, one of the blood banks that is participating in the Mayo Clinic plasma protocol. On this point, Trump was aligned with both the scientific community and the media, which touted convalescent plasma with varying degrees of nuance. “America Needs Plasma From COVID-19 Survivors Now,” went the headline of an Atlantic article. The article explained why convalescent plasma may work and why it may not. Other media coverage offered a similar cautious optimism on convalescent plasma.
Many major blood banks, such as the Red Cross, are now conducting antibody tests on blood before sending it to hospitals enrolled in the Mayo program. But some are not, and none are required to according to the FDA, which is overseeing the entire effort. There is little outside incentive for blood banks to go through this additional testing, since general antibody and more specific neutralizing antibody tests will claim valuable resources and time and, in any case, the federal government is not requiring those extra layers of scrutiny.
Dr. Reik says participation in the Mayo Clinic program “will result in the collection of data that can be used to determine its actual efficacy.” Such data is more easily collected through randomized trials than compassionate use protocols. That tension between efficacy and speed is one medical ethicists and public health officials constantly labor to address.
Still, he justifies offering patients convalescent sera, despite its yet-undetermined value. “We have people in intensive care units,” Dr. Dumont said. “Convalescent sera might help them.” There is no expectation that the FDA will mandate such tests, as they are not yet widely available. After all, even the more general antibody test is not a requirement of the FDA protocol.
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Coronavirus Symptoms Among Patients In Northeast China Are Taking Longer To Show, Doctor SaysI am a breaking news reporter for Forbes in London, covering Europe and the U.S. Previously I was a news reporter for HuffPost UK, the Press Association and a night reporter at the Guardian. I studied Social Anthropology at the London School of Economics, where I was a writer and editor for one of the university’s global affairs magazines, the London Globalist. That led me to Goldsmiths, University of London, where I completed my M.A. in Journalism. Got a story? Get in touch at isabel.togohforbes.com, or follow me on Twitter bissieness. I look forward to hearing from you.
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