The article claimed that seniors in the Department of Health and Human Services – including NIH Director of Health (NIH) Dr. Francis S. Collins and National Institutes of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony S. Fauci – intervened last week to persuade the FDA to delay an emergency use authorization (EUA) for treatment.
Currently, convalescent plasma is supplied through a program managed by Mayo under a special authorization known as an Experimental Access Program (EAP). This is a format that limits the use of plasma for hundreds of health systems too small to participate in trials, and its use is funded under the supervision of Mayo Clinic.
There are also ten or so smaller clinical trials currently underway to place plasma with a placebo comparison.
The Mayo EAP was designed to make the experimental treatment widely available in the pandemic despite no plasma supplies at the time. The move protected the FDA from issuing hundreds of approvals for treatment while building standardized protocols for collecting plasma. It also collects emerging data on safety, patient selection, dosage.
An EUA, such as that issued and then withdrawn for hydroxychloriquine, would extend the availability of plasma to all, allowing health systems in the country to begin treatment. The Times article claimed that federal health officials were concerned that early findings from the Mayo program were not strong enough to warn an EUA, leading to heavy FDA action.
“We have an extensive access protocol that continues,” said Dr. Michael Joyner, Principal Investigator of the MayoClinic Convalescent Plasma Program. “At some point that may transition to an emergency use authorization. We expect that to happen relatively soon. It has now been postponed, but the FDA is taking the time out for additional data.”
“My reading here is that there is no delay for the EUA,” said clinical researcher Mayo Plasma Program Dr. Scott Wright. “We have no idea,” Wright said when asked why an HHS official would have described an impressive approval. “The EUA has not come out, but they never had a timeline or a fixed deadline for it,” he said.
Further polluting the waters, the Times article referred to unname “senior health officials” who expressed private concerns about the rapid growth of the Mayo program. The piece claimed that “scientists have difficulty recruiting patients for randomized trials” given the availability of a Mayo alternative.
The Mayo program has grown exponentially. Since beginning in April with a plan to treat 5,000 enrollers, Mayo’s plasma program has weakened to 8,000 physicians in 3,000 hospitals serving 100,000 enrollers – from 70,000 to 80,000 of whom have now been transferred.
“That’s a false dichotomy,” Joyner said of the idea that Mayo’s large database of plasma giants is draining the nation of clinical trials.
“All of these people are being treated in places where there would never be a trial. Places like Laughton, Okla.” Studies for clinical trials, Wright added, are now being conducted in large metropolitan hospitals, locations not to suffer for participants.
The Mayo study looked at outcomes of four hours, and seven and 30 days, in relation to increasing levels of antibodies. Early findings of these patients have helped regulators understand the logistics of a plasma program, as well as early safety insurance.
The Mayo program has also treated a diverse patient population, one that has not been frequently studied in clinical trials. The patients are 20% Black, more than 35% Spanish, 10% Asian and 40% women.
However, because it has no comparison group, the Mayo data may not provide evidence of effectiveness, a critical obstacle in the approval process, and one that the Mayo clinicians easily support.
“We were never asked to do a randomized trial,” Joyner said. “We’re trying to square the security and access issues and see what we can learn about effectiveness.”
Wright says Mayo twice asked the FDA if they should transition into a clinical trial, but added that, “they said, ‘we appreciate that, but we do not think this is necessary. Let those trials register patients and you’re done. ‘”
Wright and Joyner both expressed a hope that the FDA will take the time it takes to make a careful decision about plasma.
“Even though this is COVID, it’s not uncommon,” Joyner said. “The fact that there is discussion among the various senior scientists within the Department of Health and Human Services is not uncommon. We are simply doing our duty to obtain the best data we can under the circumstances of the pandemic.”
Minnesota on Thursday, August 20 reported another 698 cases and seven deaths from COVID-19.
Outstate LeSeur and Stearns counties both placed 21 cases for the day, while suburban Dakota County posted another daily spike with 68 cases. The laboratory-confirmed case total for the state is now 67,308.
The cumulative death toll stands at 1,745.
The deaths reported Thursday included one Crow Wing County resident, two Ramsey County residents – including one in their 40s – and four Hennepin County residents. Two of the seven dead were among residents of long-term care.
The state reported an additional 13,810 tests Thursday. The state’s health systems now test more than 1 million Minnesotans, as 18.4% of the population.
Hospitals currently treat 309 residents for COVID-19, and 149 of those in an ICU institution.
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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.
