Mayo Clinic in Rochester has been at the center of the convalescent plasma program since its inception in early April. The treatment is a modern-day replication of a 19th-century method, one that predates the introduction of antibiotics and harvests plasma from recent survivors of illness in order to transfuse antibodies into the bloodstream of sick patients.
The program sprung out of a desperate hour in modern public health, one in which the global population was vulnerable to a novel virus with no known treatment nor hope of a vaccine for 18 months at the earliest.
The plasma campaign reached backward in history for a low-tech solution to the pandemic, at a time when all of medicine had been positioned to pin all of its hopes on the unpredictable, costly and often lengthy pipeline that delivers new products from the modern-day drug industry.
But some believe convalescent has since become a victim of its own success, having quickly scaled up the standardized collection, assessment and storage of the product, developed and posted protocols for treatment for a nationwide network of small-town hospitals, but never setting in place the ability to definitively prove its effectiveness.
The program cannot as designed filter out the “noise” in its findings — factors such as the ability for patients given plasma to have improved with the passage of time.
Since then, plasma has treated 90,000 COVID-19 patients, albeit in hospitals without staff to participate in rigorous trials. Mayo clinicians assert that the need for plasma did not lend itself to clinical trials at the earliest hour of the program, and that they were denied the opportunity to turn the program into a controlled trial in later months.
The announcement Sunday, Aug. 23, put the program in both a celebrated and critical light as FDA Commissioner Dr. Stephen Hahn and President Donald Trump both erroneously overstated the findings reported by Mayo, referring to a 4% improvement rate as 35%. Trump was keen to announce progress in the treatment.
Hahn’s statement that if “100 people were sick, 35 would be saved by plasma” is shockingly wrong. The risk reduction between early plasma and late plasma is relative, not absolute. In this trial, if 100 people were treated, 3.2 fewer would die. https://t.co/Fgz4MVVqNp
— Jonathan Reiner (@JReinerMD) August 23, 2020
Opinion: Convalescent plasma, which is in short supply, will rapidly become the treatment of choice for those rich enough, connected enough, and lucky enough to access it, even before knowing if it actually works. https://t.co/xnw6YEwNPj
— STAT (@statnews) August 24, 2020
With the announcement timed to tease the start of the Republican National Convention this week, Monday saw an influential chorus of best practices commentary deriding the EUA for plasma if not the Mayo program as an example of the dangers of political influence in regulatory affairs.
The FDA must approve drugs or vaccines based on their safety and effectiveness – NOT political pressure from the White House.
The President’s dangerous attempt to inject himself into the scientific decisions of @US_FDA jeopardizes the health & well-being of all Americans. https://t.co/Dt7CBVjX1D
— Nancy Pelosi (@SpeakerPelosi) August 22, 2020
The ethics of not randomizing convalescent plasma needs serious consideration. The negative consequences on public health and science are potentially huge.
— Frank Harrell (@f2harrell) August 24, 2020
“There have been a number of studies underway over the last several months looking at the use of convalescent plasma as a treatment for COVID-19,” said state Commissioner of Health Jan Malcolm on media call Monday. “It has been used successfully in other kinds of illnesses, so there’s a theoretical basis for the hopes that it would be successful, as well.
“The EUA is part of the balance of trying to get options out there … the results will have to continue to be evaluated. We are pleased the Mayo Clinic is in a leadership role in this work, and feel very good about the high quality of the analysis that they do.”
Health officials didn’t dispute the challenges of expanding a treatment that could be recalled if effectiveness is not shown, a difficult lesson of the FDA’s granting of an EUA and later withdrawing it in the case of hydroxychloroquine.
“Certainly, randomized controlled trial design is the gold standard for any sort of treatment,” said Director of Infectious Disease Kris Ehresmann, “so those will need to be done. We’re dealing with a new virus. We need treatments, so it’s that balance … we’ll have a much clearer picture of the benefits of this as a potential treatment with more research.”
Health officials Monday also noted that school districts in the tiny southern Minnesota towns of Ivanhoe and Minneota needed to quickly delay plans to offer in-class instruction, as new cases of COVID-19 were recorded over the weekend.
“This just shows how quickly circumstances can change,” Malcolm said. “It’s a reminder that with this virus, school districts could be facing a scenario where they are planning on one learning model, and all of a sudden they need to turn on a dime before the next morning.”
Also on Monday, health officials reported that the Minnesota cases traced to the Sturgis Motorcycle Rally earlier this month in South Dakota have now reached 27, from 25 separate households, with one hospitalized patient having been released after three days.
The state of Minnesota reported another 717 cases of COVID-19 on Monday, Aug. 24. The new cases bring the laboratory-confirmed case count to 70,298.
The new cases Monday were spread widely across the state, in 61 of the state’s 87 counties. Dakota County in the southern metro, population 398,000, reported 75 cases Monday.
Rice County, population 64,000, reported 26 cases; Stearns and St. Louis counties each reported 20 cases.
An additional four deaths from the illness were reported on Monday, with one death each in Hennepin, Ramsey, Scott and Waseca counties. The death recorded in Ramsey County was a resident between the age of 35-39.
Three of the four deaths were among residents of long-term care. To date 1,771 residents of Minnesota have died of COVID-19.
The state’s health office reported another 12,296 tests on Monday. To date, nearly 1.07 million Minnesotans have been tested for the virus.
Currently there are 310 Minnesotans hospitalized with COVID-19, with 135 in the ICU.
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- Minnesota Department of Health COVID-19 hotline: 651-201-3920.
- COVID-19 discrimination hotline: 833-454-0148
- Minnesota Department of Health COVID-19 website: Coronavirus Disease (COVID-19) website.