August 25, 2020

FDA Approves Plasma Treatments

“The U.S. Food & Drug Administration (FDA) on Sunday said it authorized the use of blood plasma from patients who have recovered from COVID-19 as a treatment for the disease, a day after President Donald Trump blamed the agency for impeding the rollout of coronavirus vaccines and therapeutics for political reasons.” Reuters

A study by the Mayo clinic referenced by the FDA noted that those transfused with higher levels of antibodies were less likely to die (11% died rather than 14%). That means out of 100 patients, an additional three survived with the treatment (a 21% decrease in mortality as the difference of 3 people is 21% of 14). FDA

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From the Left

The left worries that the FDA’s decision was based on political calculations rather than scientific consensus.

“In announcing the new decision, the president and his team have vastly overstated the promise of convalescent plasma… Dr. Stephen Hahn, the F.D.A.’s commissioner, went so far as to suggest that the plasma therapy could save the lives of 35 out of every 100 coronavirus patients who took it. As STAT News reports, the number is much closer to three to five out of every 100, and even that lower estimate is questionable: The data came from an observational study, not a rigorous clinical trial…

“Dr. Hahn could have made a more honest case for authorizing plasma therapy by simply pointing to the urgency of the moment and the apparent safety of the treatment. The administration could have helped resolve the questions around convalescent plasma by arranging for more rigorous clinical trials. That it instead chose egregious overselling of its benefit is unconscionable.”
Editorial Board, New York Times

“Remember when he said that hydroxychloroquine would prove to be a miracle drug? Or that Americans would be back in church by Easter? Or that the virus would go away on its own? Of course, none of these assertions ever came to fruition… Perhaps this time will be different. Perhaps Trump — and Americans — will get lucky, and convalescent plasma will prove to be the miracle he says it is. But the president might be better served if he dealt more humbly and honestly with the massive challenge presented by COVID-19.
Joel Mathis, The Week

“None of this was an accident. It was carefully designed to mislead the lay public into thinking that Trump had decisively ripped a miracle treatment out of the hands of the stupid doctors and made it available to everyone. He didn’t. Tens of thousands of people have already received plasma treatment and that will continue with little change. Eventually more careful studies will be done and we’ll have a better idea of just how well this treatment really works.”
Kevin Drum, Mother Jones

“The vast majority of people infected with the virus get better on their own. Determining whether a treatment can actually hasten recovery from the illness requires controlled clinical trials. This means randomly sorting people into two groups — one that receives the treatment and one that receives a placebo — and then monitoring their progress with the disease. And that data is still lacking for convalescent plasma… It becomes harder to recruit patients into clinical trials where they may receive a placebo if they know that they could get the actual treatment from their doctor… This treatment also carries risks. Plasma transfusions can lead to complications like acute lung injury and severe allergic reactions leading to anaphylactic shock. These are not common outcomes, but the risk isn’t zero.”
Umair Irfan, Vox

“Eager for good news before Election Day, Mr. Trump risks undermining public confidence in vaccines and therapies at a critical moment… The temptation to take shortcuts is dangerous. This will be the largest mass immunization program in history. To successfully confront the pandemic, a vaccine must pass through a complex development and testing process, then be manufactured and distributed to exacting standards. Any slip-up can be catastrophic, not only in medical terms but in people’s confidence. Vaccine hesitancy, spread by misguided campaigners on social media, is already a serious problem. A mistake could endanger the whole enterprise — an effort Mr. Trump proudly and repeatedly boasts about — and leave people suffering far longer than necessary.”
Editorial Board, Washington Post

From the Right

The right supports the FDA’s decision given the potential to save lives and lack of alternative treatments.

The right supports the FDA’s decision given the potential to save lives and lack of alternative treatments.

“Mr. Trump was wrong to tweet over the weekend that ‘the deep state’ at the FDA was thwarting development of therapies and vaccines to sabotage his re-election. There’s no evidence for his claim or that the FDA is making decisions based on anything but the science. There is, however, ample evidence that convalescent plasma may be effective and that the potential benefits outweigh the risks…

“The most persuasive evidence comes from a Mayo Clinic study, which has enrolled 90,000 hospitalized subjects since April. Although the study doesn’t include a placebo group for comparison, mortality was 21% lower among non-intubated patients treated with plasma containing high levels of antibodies versus lower levels…

“We’ve written for years about a risk-averse FDA culture that blocks promising therapies because they only helped a subset of patients or because trials weren’t designed according to the gold standard. This becomes unethical when it blocks treatments such as convalescent plasma that pose no serious safety risk but could save lives against a deadly disease. If later studies show little benefit, the FDA can withdraw its EUA. For now it is right to make saving lives the first priority.”
Editorial Board, Wall Street Journal

“The objection isn’t so much that the plasma might cause harm, it’s that resources that could be devoted to more promising treatments will now be devoted to plasma without any idea as to whether it works or not. It’s the hydroxychloroquine fiasco all over again — which, ironically, is part of the reason why we don’t have any clinical data on plasma right now…

“I continue to think Trump will get no benefit from a vaccine-related October surprise *if* there’s any evidence that the process has been expedited for political reasons. He’s not trusted on COVID matters beyond his own base; pushing out a vaccine before scientists are confident that it’s effective will set up a clash of credibility between them and him, and he won’t win that clash. If anything, it’ll hand Democrats ammo to argue that he’s willing to treat Americans as guinea pigs for his own selfish electoral interests. I think the days of the FDA’s, ahem, ‘deep staters’ standing in his way are over, though.”
Allahpundit, Hot Air

“The use of convalescent plasma is not novel to scientific discovery. In fact, it’s been used for nearly a century treating various conditions… It may not be the magic ticket to end the pandemic, but can it save lives if sufficient quantities of [antibodies] are given early enough?...

“While there may be some people attempting to dampen the enthusiasm of the announcement, any treatment that is proving safe and potentially efficacious after being administered in over 70,000 Americans deserves praise. Convalescent plasma is currently being used across the country under an expanded access program but the EUA gives further access by cutting through potential administrative delays.”
Nicole Saphier, Fox News

“The treatment has already been given to 70,000 Americans and — according to the FDA — has shown effectiveness… Should we have to wait, in the midst of a pandemic, for full results from randomized control trials before authorizing its use in hospitals? There is a very big difference between authorizing a drug for use with a limited number of people who are already desperately ill, and authorizing, say, a vaccine that is going to be administered to almost a country’s entire population. A much higher level of risk is appropriate in the first instance than in the second.”
Ross Clark, Spectator USA

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