Trump and FDA Misrepresent Data as They Tout Blood Plasma Treatment
In a news conference on Sunday, President Trump alongside Stephen Hahn, the head of the Food and Drug Administration (FDA), and Alex Azar, the secretary for Health and Human Services (HHS), touted the efficacy of blood plasma in treating COVID-19 as they announced its approval for a treatment.
And yet, the data they cited was misrepresented and built on a shaky foundation, forcing Hahn to walk back his assertion that it was an effective treatment, a rare about-face for an agency that is supposed to be an anchor of non-partisan public trust, according to Bloomberg.
In fact, just days before the FDA approved the treatment, a group of top health officials that included Anthony Fauci and Francis Collins said the emerging data on blood plasma treatments was too weak to justify its approval. Yet President Trump, who had also accused the FDA as being part of the "deep state" that was delaying treatments until after the election, touted blood plasma treatment as reducing deaths by 35 percent.
The problem is, nobody knows where that number came from. As The New York Times reported, it was not found in the FDA's official authorization letter, nor a 17-page memo written by FDA scientists, nor in the Mayo Clinic analysis cited by the administration.
"For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy," said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, to The New York Times.
In an interview with new agencies, one of the Mayo Clinic study's main authors, Dr. Arturo Casadevall of Johns Hopkins University in Baltimore, expressed confusion. "Do I know where the 35 percent comes from? No," he said, as The New York Times reported.
"That was not the way that I would have worded it," he added, as Bloomberg reported. "I hope they will issue a clarification."
"You need to correct the 35 lives saved per 100 sick with COVID-19 so people understand that was absolutely wrong, Steve," wrote Eric Topol, director of the Scripps Research Translational Institute in California, on Twitter, as Bloomberg reported. "That there is no evidence to support that. That there is no evidence at this juncture to support *any* survival benefit."
As the criticism of the 35 percent number piled up, Hahn listened. He acknowledged its validity last night in a tweet.
"I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma," Hahn wrote. "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."
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.— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
The treatment in question, convalescent blood plasma therapy, uses antibody-rich plasma from people who have recovered from the disease to help ramp up the immunity of sick people so they can develop their own antibodies. However, there are few randomized controlled trials to demonstrate its efficacy, according to STAT News.
"Investigators have had challenges enrolling patients to begin with, and this announcement will make it even harder, if not impossible," said Dr. Howard Koh, a professor at the Harvard T.H. Chan School of Public Health who was assistant secretary for health in the Department of Health and Human Services in the administration of President Barack Obama, to NBC News. "It's a disservice, actually."
According to Bloomberg, the data simply shows that a higher dose of blood plasma is more effective than a lower dose. While there are promising results, the extensive research has not yet shown that blood plasma therapy is far superior to a placebo.
"Until we have a randomized controlled trial, we don't know definitively," Casadevall said.
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Hundreds of endangered sea turtles were stranded on beaches after suffering "cold stunning" in the waters off Cape Cod, Mass. Local rescuers and wildlife rehabilitators stabilized the turtles at the New England Aquarium (NEAQ) and National Marine Life Center and began treatment. Many of the sea turtles were transported by land or air to partner facilities around the Eastern Seaboard for longer-term care to make room for more incoming, cold-stunned animals.
Rehabilitators at The Turtle Hospital in the Florida Keys assess critically endangered, cold-stunned Kemp's ridley sea turtles flown in after rescue in New England. The Turtle Hospital<p>NEAQ and local rescuers begin seeing turtles every fall when water temperatures drop to that 50 degrees F threshold, and typically expect to find them into early January. After that, <a href="https://www.ecowatch.com/sea-turtle-cape-cod-weather-2621527394.html" target="_self">temperatures are so cold that any animals found are usually no longer alive</a>.</p><p>Merigo estimated that this year's cold season "looks very busy" and noted that local rescue efforts had already surpassed 400 turtles.</p><p>"It is a lot of animals. They're still coming in," she told EcoWatch as she surveyed 39 rescued turtles that day and 20 the day prior. "So far, this is a huge year."</p><p>At NEAQ, the turtles are gradually warmed up about five to 10 degrees F a day. More aggressive warming can cause serious damage and the turtle might not survive, Merigo said. Emergency treatments also include providing replacement fluids, balancing electrolytes and addressing pneumonia. Assessments take place for other serious problems too, such as shell or limb fractures, frostbite, emaciation and eye damage.<span></span></p><p>As local aquariums don't have the capacity to care for all the injured turtles, a group of private pilots called <a href="https://www.turtlesflytoo.org/" target="_blank">"Turtles Fly Too"</a> donated planes, fuel and time to transport some to various partner facilities around the country. Other turtles were driven to closer care facilities.</p><p>"We have a huge network of really great partners working with us, so if we can spread out the care, we can give better care to all the animals," Merigo said.</p><p>The 40 Kemp's ridley sea turtles recovering in The Turtle Hospital will continue to be treated and rehabilitated anywhere from 30 days to a year, depending on the severity of injuries, Zirkelbach said.</p><p>The turtle expert noted that while she's treated cold-stunned turtles from the north before, the newest arrivals were the most cold-stunned Kemp's ridleys ever received at one time.</p>
After rescue, cold-stunned sea turtles received immediate emergency care and assessments at the New England Aquarium. Caitlin Cunningham / New England Aquarium<p>In the past decade, the Gulf of Maine, which spans from Cape Cod to Nova Scotia, has warmed 99 percent faster than the rest of the ocean, Zirkelbach said. The warm water encourages turtles that migrate north along the Gulf Stream in warmer months to stay in the bay longer.</p><p>"Turtles that fail to migrate south get stuck in the unique horseshoe-shaped topography of the Cape Cod peninsula, and when temperatures drop, the bay becomes a death trap," she added.</p><p>Before ocean temperatures warmed, the waters of Maine were too cold for many of these sea turtles, Merigo echoed. Now, with warming sea surface temperatures, Maine can reach the high 70s to low 80s, which is "perfect turtle temperature," she said. The potential for more turtles getting trapped in the bay and then cold-stunned is nerve-racking for Merigo.</p><p>In addition to shifting habitats as waters warm, warming global temperatures also disrupt natural gender balance in sea turtles, Merigo warned. Gender is determined by the temperature of eggs in nests, and as the planet warms, it will result in all females at some point, she said.</p><p>"The turtles we work with are all endangered and threatened," Merigo said. "For sea turtles in general, the future is a little grim. Climate change is real; it does impact them."</p>
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