Convalescent plasma approved by the FDA

I’m sorry I can’t even agree that I know what we are disagreeing about.
Honestly I don’t know what parts of my discussion are raising your dander

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Am I encouraged yes. Excited no. Is it ground breaking no.

You know it was not conducted just at the Mayo Clinic? It was conducted at 2800 locations in the US and territories.

It was a preprint and has not been peer reviewed.

Mayo’s study was not a randomized, placebo-controlled or blinded study, meaning that it can’t be used to prove whether plasma treatment actually works. That’s because there could be a number of other, uncontrolled variables that could affect the results in an observational study like this one.

The only way to prove whether this type of treatment works is through a controlled study where researchers compare results between patients who receive plasma and patients who receive a placebo instead of plasma. Neither the patient nor the researcher knows who got what until the trial is complete.

One big issue is about relative risk reduction and absolute risk reduction. It is the mistake first year med students make.

But don’t take my word for it.

It seems SteveFDA is walking it back now.

https://mobile.twitter.com/SteveFDA

[
Dr. Stephen M. Hahn
@SteveFDA

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.

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Mayo clinic is legit. But if you read the actual findings and the methodology, you quickly discover that it is more of an aggregation of very loose data and not a formal trial that establishes anything concrete. Very preliminary findings, which is fine. The issue is that it is being framed as being something that has proven scientific efficacy. But if you read the report itself, it will state very plainly what the limitations of the study are

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And this is why the words the president says and those he parades out matter…give it a few weeks and will will add people drinking Oleander too.

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They forgot to mix that bleach with ammonia first. It’s much more potent.

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This also illustrates the danger of the president announcing “major medical breakthroughs”. No one in medicine is saying that about convalescent plasma, including Mayo (which we in Minneapolis refer to as the WFMC). But now he says it and people now won’t accept anything but agreement that it’s a major breakthrough. This treatment is widely known and used because it makes sense to try it. While it’s being evaluated is not the time to overhype it. It’s going along fine without outside pressure for it to be a major breakthrough. Over a hundred thousand patients have been given this at almost 3000 institutions. Its is not a secret hidden treatment only Mayo knows about and they need to get to word out to everyone else.

It’s great to have treatment options. It’s wonderful that we treat covid better than we could months ago and lives are being saved. Let’s just not make this out to be more than it is.

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I see this with pretty much every issue. Whatever he says gets parroted as the new talking point.

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Since you are a doctor, can you explain the difference of absolute risk reduction and relative risk reduction?
When reading the info on plasma, I understood that it wasn’t reducing overall mortality rates by the 35% quoted, the way some people are interpreting it, but I don’t know what it’s real effect was.
Also, for those that don’t get why a data study, with no peer review, as opposed to a double blind doesn’t work… all the improvements could have been from something like Dexamethasone, which we know helps those with Covid.

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FDA Chief walking back how he framed the Convalescent Plasma findings after getting blasted by the scientific community

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To understand the confusion over the 35% figure, it’s important to look at two concepts: relative risk and absolute risk.

Imagine a clinical trial to test an experimental drug, with 2,000 patients split into two groups. The first 1,000 patients don’t get the drug, and in that group 10 people die. The other group of 1,000 patients gets the drug, and five people in that group die.

Using relative risk, that’s a 50% improvement – a tremendous number. But using absolute risk, the imaginary drug only decreases the likelihood of death by 0.5%. That means 5 more of those 1,000 people treated with the drug would live, not the 500 implied if you mistakenly use the 50% relative risk number.

The claim of a 35% mortality benefit made by Trump, Azar and Hahn uses the first measure – relative risk. But because clinical trials of plasma therapy haven’t been completed, how many lives it actually saves – the absolute risk improvement – still isn’t known.

https://www.bloomberg.com/news/articles/2020-08-24/fda-trump-officials-misrepresent-key-statistic-on-covid-therapy

But it is like squeezing toothpaste from a tube, the idea is out there now and can’t be undone. All this does now is undermine the public’s confidence. That is why many are fearful that a vaccine will be politicized and rushed. We only get one real chance to get the confidence and trust in a vaccine right.

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Obviously the Deep State got to him.

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He is trying to salvage his reputation. He is being “peer reviewed” by his peers online. It is savage.

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Yes he jeopardized not only his credibility, but the entire FDA

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November

Good for him to adjust his comments. He clearly talked too EARLY
Now Eric and JV does this Mayo Clinic data show a greater % than they had earlier?

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” the commissioner said in a string of tweets. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”

Yep, it was an unfortunate use of words for someone in his position and profression where words matter. But he corrected it within 24 hours and it didn’t change the justification or the decision on the emergency use. declaration by the FDA.

I wonder what percentage of the American population even understood the significance of his words either time? 0.001%?

*The authorization was based on anecdotal data from a 70,000-person program run by the Mayo Clinic.

When a doctor makes the above statement to a recently infected pateint with COVID at TMC tomorrow, the patient is going to immediately say can I get myself some of that convalescent plasma in a NY minute? :grinning:

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I don’t know what the percentage is is but obviously higher than that. Of course, I’m sure that was sarcasm.

In the end, the words were discussed and debated even on this board. And, if someone didn’t understand initially, they could quickly learn as this blew up on social media from people that did. Either way, the FDA isn’t only giving guidance to the average American. In fact, I’d guess the average American doesn’t directly pay much attention to them. That guidance was more directly given to people that understand the words.

The FDA knows words matter which is why they walked back the statement. Their credibility would have been shot otherwise.

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This is just another chapter in the pattern of low-key disinformation that has been happening since February. People distorting facts to sell a narrative to the public. The problem is that not everyone knows how to interpret data, read a scientific study, or read news articles with a critical mind. Let’s face it, those of us here have college degrees from UH. A lot of people do not, and a lot of people rely on public officials and the media to interpret the facts for them. Same reason people dismiss covid as being another flu virus, don’t understand why masks are necessary, think kids can’t catch COVID, and drink fish tank cleaner.

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I do a lot of legal related work within our services with lawyers non-stop on both sides of the equation. That is why I made that point that words matter. But it mattered to his immediate peers within his profession. The far vast majority of the general population it passed right over their heads, if it even did pass over their heads at all. I was being funny or sarcastic with the % listed, but the overall number is very small, and he did correct and clarify it within 24 hours, and it didn’t change anything with the path forward or their emergency use designation. Only further validation of the treatment will change their emergency use designation in either direction.

And the vast majority who get infected who are getting sicker will be inquiring about its treatment and the treatment for them with their doctors, as they should and hopefully it will be more available with the emergency use designation by the FDA to help more people get cured going into the future than in recent history.

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If anything, I’m more disappointed that someone in his position didn’t understand or have the ability to explain better initially. Or at least had someone working for him that could counsel him.

Because the other explanation for what happened is worse.