Updated: August 20, 2020 08:05 PM
Created: August 20, 2020 07:17 PM
Mayo Clinic is responding to reports about the status of convalescent plasma, a nationwide experimental treatment spearheaded by the Minnesota hospital.
The New York Times reported Tuesday that the U.S. Food and Drug Administration decided to put an emergency authorization for blood plasma as a COVID-19 treatment "on hold." They said top federal health officials argued "emerging data on the treatment was too weak."
"We were not surprised they wanted more data and they may still need more data going forward," said Dr. Scott Wright, a professor of medicine at Mayo Clinic and one of the leaders of the convalescent plasma program.
About 70,000 COVID-19 patients across the country have received plasma under the expanded access program. Mayo Clinic said studies have shown plasma is a safe treatment but its effectiveness is still under review.
"We have a preliminary indication that it is working at least in some patients," Wright said. "We're pleased with the data we see and we're optimistic that it will continue to uphold the observations from the first data set we sent to the FDA."
Wright said the FDA update mentioned in the New York Times' report would simply mean plasma does not have "emergency approval" at this time. Plasma will still be available but patients will have to sign a consent form to receive it.
"Plasma is not ever thought to be a miracle drug," Wright explained. "It's been a longstanding treatment for over 100 years. It is one strategy but it's always used as sort of a preliminary way or 'stopgap' until more commercially available products become available and are proven to be safe and effective."
He believes the FDA will try to validate Mayo Clinic's initial observations about convalescent plasma before making any further decisions.
"Let them make their decision as they do as a regulator. Make the best decision for the people of the United States. That's what we want and that's what I think every physician and scientist working in COVID wants," Dr. Wright said.
5 EYEWITNESS News also checked in with infectious disease doctors in the metro for an update on other drugs and therapies being studied.
"In the real world, we have to make the best judgment we can with the best information we got," said Dr. Frank Rhame, an Allina Health physician at Abbott Northwestern. "As we get better studies, sometimes things change."
Rhame treats critical COVID-19 patients. He said, for patients who need to be on oxygen, they typically use a combination of plasma, dexamethasone and remdesivir.
Currently, dexamethasone and remdesivir are the only two drugs officially recommended as COVID-19 therapies by the National Institutes of Health.
Remdesivir is an antiviral that Dr. Anthony Fauci said showed "modest effect" in diminishing the recovery time for people who are hospitalized and require oxygen, with a 32% faster recovery.
Dexamethasone is a steroid. A large study out of the UK showed it may reduce mortality by 36% for patients on ventilators.
Fauci said many other drugs are still being studied, including immunomodulators, anticoagulants and monoclonal antibodies.
"To me, I think the two most promising trials underway are monoclonal antibodies, very interested in those trials," Rhame said. "In those, you figure out a strong antibody and you make it in vast amounts. You make a clone and you make it over and over and over again and you use it to make that same antibody many, many, many times."
The use of hydroxychloroquine has also been hotly debated in recent months.
"We've had five randomized trials now of hydroxychloroquine, and in none of them were benefits shown," Dr. Rhame said.
Gov. Tim Walz also said the drug has been proven not to be an effective treatment for COVID-19. In an earlier executive order, he had put prescription restrictions in place due to high demand. He lifted those restrictions last week.
Regions Hospital is now one of 40 sites testing a new COVID-19 drug called AuxoraTM, which is an inflammation-blocker.
"This is a whole team effort. Hundreds of people are working on this study," said Dr. Charles Bruen, a critical care physician at Regions. "There's so much work being done, reliable scientific work, to get real answers."
He said Auxora has shown promise for patients with severe COVID-19 pneumonia.
Bruen urges the public to pay attention to the emerging science and look closely at the data.
"There's a lot of bad science going on, things rushed to be published. I would just encourage anybody who's looking at things, look at stuff that's peer-reviewed, that has some checks and balances to it," Bruen said. "Is it good science? Has it been done well? Have experts outside of the research projects themselves looked at it? That's how you discern what's currently known and what's anecdotal. It changes over time. Right now, the pace of information is remarkable."
Mayo Clinic issued the following statement to KSTP Thursday:
"At the request of the U.S. Food and Drug Administration, Mayo Clinic and its collaborators quickly mobilized to help severely ill, hospitalized patients with COVID-19 at the height of the pandemic and to determine the safety of convalescent plasma. The use of convalescent plasma is a treatment approach that has long been utilized for various conditions and, in some cases, demonstrated significant improvement in health and mortality rates.
"According to the FDA, the national Expanded Access Program (EAP) is designed to meet these criteria: access to investigational convalescent plasma and its safety. The study has met those criteria. While the program is not intended to be a clinical trial to determine the efficacy of convalescent plasma, in the course of our work, we observed possible signals of efficacy and chose to share that data. The data could advance the discussion about the efficacy of convalescent plasma treatment, and we acknowledge that additional scientific investigation is needed.
"The FDA has asked for additional data for review by their teams, and Mayo Clinic is providing that data. The discussion and simultaneous analyses continue. We welcome that further review.
"We agree on the need for randomized clinical trials (RCT) as a scientifically sound approach. We believe the data from the EAP is significant and could be used to provide evidence to conduct RCTs going forward. We will always support bolstering the best science that will result in the most effective treatment for patients and welcome methodical scrutiny of our data.
"Mayo Clinic is committed to addressing the unmet needs of patients. In the midst of a national emergency – and at any time – we are proud to share our expertise as a leading voice in health care to help save lives. As with any medical treatment, we believe that the choice of the appropriate care plan is a decision to be made by the physician and the patient, and the data provided may offer useful insight in making those decisions. We're confident in the data we've provided to the FDA and the scientific community and look forward to continuing to contribute to a medical solution to this pandemic."
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