triplehorn

Stop saying this. American Journal of Epidemiology: Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis "Five studies, including two controlled clinical trials, have demonstrated significant major outpatient treatment efficacy."

You're missing the point. It has a longstanding and well established safety profile. In a risk/benefit scenario, it's so safe that people take it with no existing medical condition, and with only a *chance* they will be exposed to the malaria protozoa. No one is trying to put one over on their patients or trying to coerce them. Anyone prescribing it off-label should be doing 1:1 due diligence for standard medical screening and consent like for any other on-label or off-label consideration. A lot of people will remain afraid to ever consider it, even with their own positive Covid-19 test, and that's perfectly fine. We need to adhere to evidence based approaches whenever and wherever possible, but medicine in real time practice during a deadly novel pandemic creates real pressure to go outside of that limit to immediately save lives. Please drop the blanket off-label malpractice diatribe.

Ok, in this specific EUA case, "the product" was a specific batch of HCQ held in bulk in US stockpile that was manufactured in Pakistan that lacked adequate production certification. It was not generalizable to "all sources" of (H)CQ. I think that's where the public confusion arises and what the Trump official explains if you go back and listen. total public messaging clusterfuck. Hold up here. HCQ is primarily used as pre-exposure prophylaxis in healthy unaffected people. So we're talking about millions of doses of HCQ being taken for decades by people WITH NO EXISTING MEDICAL CONDITION that would warrant taking it. Think about what you're saying.

Re-linking this PDF from bottom of last page. There's quite a lot out there. How do you derive this assertion?

Wise choice. No one is giving HCQ when you're hospitalized anymore. Alternatively, no one is getting IV/IM dexamethasone sitting at home with early uncomplicated symptoms.

"You are absolutely wrong. The media has reported the FDA policy change correctly. The FDA has reported the science correctly. The Trump official was trying to spin the FDA policy change." - I'm still trying to understand exactly what happened, but I took it to mean that by the FDA retracting the emergency approval of HCQ in hospitalized patients, they are essentially saying "you do not need our emergency approval to apply this medication for off-label use." In effect, I took it to mean their emergency approval was saying that by default all other applications required similar emergency approval. My understanding is that limit is gone now. Other aspects of what you assert may very well be accurate and in effect without any conflict with the former change. "Here is the way medical science works: it is the responsibility of the person making a claim that drug/treatment provides a benefit to PROVE it. The FDA policy change stated the simple fact that there is no proven benefit to HCQ. It went further and stated that NIH guidelines no longer just recommend HCQ usage for clinical trials, but actively recommend NOT PRESCRIBING HCQ outside of clinical trials. [...] "Basically, any doctor prescribing HCQ for Covid-19 outside of the clinical trial setting and without fully informing the patient that we have no scientific evidence of benefit and that there are known risks to HCQ is committing medical malpractice. Full stop." " - Look, there are at least half a dozen or more widely applied off-label uses of HCQ, and for conditions a lot less likely to put you in the ICU on a vent, or dead within weeks. Why isn't the FDA dropping the hammer there? I expect it's because of safety. HCQ has a robust and very long track record for safety. Yes it carries some risks, but that can be avoided when use or not is determined 1:1 under medical supervision, like so many other examples. That gives the medical community a much wider space to find ways to help sick patients. So the risk/benefit of using HCQ in a patient without contraindications to treat Covid-19 tilts heavily in favor of early use of HCQ. And the evidence is mounting internationally (and less reported in the US) that early application of HCQ has a mitigating effect on course and severity of Covid-19 illness. You saying no scientific evidence of benefit exists is a head scratcher. Here's a helpful PDF file of world studies to date

corona free *

Re dexamethasone, great news if true. Another old generic repurposed drug from the 50's? If only they turned profits for big pharma.

Above, I pointed out that what was said about the FDA policy change was misunderstood in this thread. That's all. The Trump official at the table explained it. The communication and messaging around everything is just so mangled. And again, in the bulleted information you included, the studies and conclusions almost entirely relate to hospitalized patients with advanced illness. People's understanding is fixated on the results of late stage application. Can someone point me to a US study on early application where mitigation of illness severity or incidence of need for hospitalization was measured? A single US study? On the international front, there's been quite a bit of arrogant ridicule of international scientists and physicians they disagree with, and mocking of preprints and published non-US research. In the meantime, there is mounting evidence internationally that early application is where the effect is observed. Regarding the kids warning and malpractice scare, welcome to medicine! No kid should have access to your prescriptions ever. That's includes your Tylenol which can also be fatal. Informed consent goes along with any prescribed use of medication, whether it's on or off-label. And HCQ is a lot less likely to cause any meaningful adverse event in 5 days of use than a multitude of medications prescribed for their FDA approved use. People are acting like off-label use of anything by definition is some rogue act. It's not. Are there some off-label uses that are not safe and completely unsupported by anything? Yes, of course. But that is not the case here. So today, at the federal level, HCQ can be used off-label in the US for early intervention of Covid infection. However some individual States may still have policies in place that restrict use to hospitalized patients or clinical trials.

[truther warning] So here's the vid of rest of that Trump guy's explanation on the FDA's reversal and what it means: Taken together, what that guy says is that not only did the FDA do the opposite of what the public understood it to mean, but also is it perfectly acceptable to prescribe this drug for any off label purpose including covid. Then he casually lets it glide that early application is the direction it's headed. Trump can't comprehend, let alone parrot, something so basic to save himself. He just murders all mental coherence. where we are today --> outpatient doctors and patients have the freedom to increasingly opt for early application of this med with a positive or presumed pos diagnosis. The catch is, it won't be about whether you personally want to take it or not, it will be about whether you have rapid access to efficient health care to provide it. The lack of an organized federal effort to coordinate anything that could amplify any positive outcome kind of renders it irrelevant.

I unplugged for over a month this spring. I log in and my Notifications are a solid column of jimi hendrix faces. It was a little weird. I've seen a lot over the years, but this was new. It doesn't take a randomized controlled trial to conclude he's obsessed with something. like a heat seeking suppository. I'll do the simple thing and put Anastasis on ignore. Doesn't mean his mentions and call outs will end, but it'll help curb the back and forth shit pile for the rest of you.

new study out: Pre exposure Hydroxychloroquine use is associated with reduced COVID19 risk in healthcare workers n=106 in cohort study. good discussion section in the full .pdf version at the link. This is the second study out of India significant for PEP. We have no pre-exposure prophylaxis studies out in the US. This effect resembles what you see with the HIV PEP med Truvada. If while having been taken daily exposure to the HIV virus happens, HIV infection is neutralized. If it's not being taken and exposure to HIV happens but it's started 72 hrs later, good likelihood infection happens, which is exactly what has been found in two US post-exposure prophylaxis studies to date. Compared to Truvada which has to be taken once daily, HCQ is being taken once per week, and at the same dose and frequency used by millions of people for malaria prophylaxis over the last half century.

Makes perfect sense. It's foolish by now, but I still try to take seriously part of what you say in this subject. I can let go of that now, not because you're not being serious or not, but because there's no first hand experience to relate. Science is data and math. Medicine is that plus relationships. When someone care for expresses to your face intense fears for their life when there are no proven options, you have a conversation about things that may or may not work and form a mutual understanding around difficult unknowns. That's where we are with Covid-19. Right now, there are over 50 countries formally employing the use HCQ + AZ. Globally, it is the the most used pharmacologic intervention to treat Covid. Even though RCTs are gradually appearing, thousands of physicians in the trenches around the world and in the US have been using this intervention and are observing some benefit when used in specific ways, or at a minimum, basic safety in the absence of benefit to justify going forward. RCTs may ultimately show no benefit in any context. But you calling it "quackery" is the height of insensitivity and arrogance. Or considering how far you've drifted out of your lane, maybe it's not insensitivity and arrogance, Dr. Rosenpenis.

Are you a medical doctor, an MD ? I have to ask.

When he sees this flag on the final lap, he keeps surrendering. Now we know why.

@Anastasis "Yes, I have not been in the clinic for quite some time, but your sense is wrong my friend." - stay frosty. "Once again, you fail to acknowledge the basic concepts underlying evidence based medicine, and how the various levels of evidence should translate to clinical practice." - Sounds like an EMAW "circumstantial evidence isn't admissible as evidence in a court of law" moment. When you have to make a definitive move, never settling with not knowing everything will paralyze you, then eat you alive. An OCD type can only carry you for so long in the red zone. "This is quackery." It's hard to conceive of day when I've been asked a clinical question where I didn't say "I don't know" at least once to something where knowing the answer would impact decision making, and yet decisions were made. There's an unknowable granularity to every complex decision. That's what I'm speaking to. But quackery? You're coming at me from someplace else.

I recall you saying you have not been involved in clinical work for awhile. Don't what you did in that capacity, but my sense is that you weren't engaged in direct medical decision making with patients having critical medical or mental illness. Your approaches and tools aren't limited only for uses that have been subjected to randomized controlled studies. RCTs are great to have to help inform understanding and use. RCTs can be very important in what gets FDA approval or not. They can form underpinnings of medical-legal considerations. They help establish procedures and treatments that insurance will pay for and prescription uses for which people won't have to pay out of pocket to acquire. RCTs are the most solid reference point, but there is a vast territory in medicine that is not mapped out by RCTs. There is an awful lot to be said for direct clinical experience - having lots of repetition, and lots of outcomes under careful observation. A knowledgable and experienced clinician can navigate to safely give a person the best chance to survive and heal in the moment when their life and wellbeing is on the line, and when there is no textbook answer or randomized trial to reference. That is what is happening here x10 with Covid-19.

for someone so critical of having RCTs to back a stance, you're dealing in hypocrisy in that you clearly have made up your mind. And another cheap, generic, FDA approved for safety antiparasitic with signs it's effective against Cov19. This one helping late stage complicated illness:

We can go round n round about it. You've set your bar at RCT. There are a lot of sound reasons a broad range of other study designs exist. They have meaning and applicability. The main advantage of HCQ, which I expect is backed by numerous RCTs spanning decades, has to do with established safety and known risks to consider. Once you have safety in hand, it gives clinicians a lot more leeway to rapidly search for applications where saving lives can occur before you can complete comparatively time consuming RCTs on various specific targeted uses. this is a war, not a half speed drill. Other rapidly applied study designs have already been done that suggest a benefit under specific conditions. If safety is known, and it costs about $0.60 per dose, there should at least be support for providers and their informed consenting patients opting to take it if it might help. We're at 110,000 dead Americans just 3 months into this fight. It's obvious from the actions of numerous nations and their medical communities that they are seeing benefits from how they are incorporating it, and that it's safe at a minimum. I don't believe those involved in such national policy decisions are reckless or dumb. In fact, most everyone is kicking our asses across the board in efforts to fight this virus. But again, it was Trump's gross mishandling of the subject of HCQ with the public that resulted in the FDA having to oversteer to keep the public from taking aquarium cleaner and gargling bleach, and to shut down access and use through legitimate medical pathways. The secondary result was most everyone suddenly rejecting being in a HCQ study based on misplaced fear and/or negatively associating it with Trump. Too much is still at stake to blow this.

latest variation: #BunkerBitch

The relevant information (bolded) from the MD/MPH's tweets above : " The 4/24 FDA announcement on dangers of #HCQ pretty much killed any further enrollment. (Graph is US only). This happened in all US trials." The lack of study reports produced by the US compared to what the rest of the world is generating is striking. If you don't have willing subjects, you don't get results one way or another across all experimental designs.

Your’re on a tangent. Whether or not post-exposure prophylaxis works or not (it appears to not work), it still leaves unanswered important questions about application for early infection mitigation and pre-exposure prophylaxis. But our pool of enrollees for these studies collapsed due to scary distortions of information and irresponsible communication (Trump). On the separate matter of overpowering a study, big pharma is known for this such as for repurposing a failed drug meant for something else. They have unlimited funds for very large studies to pull statistically significant findings out of a hat, and unlimited funds to market it however they want. “We found a statistically significant finding that subjects averaged 15min more sleep per night with this stuff. At least we have ourselves a sleep med!”

What prospective interventional trials? That’s the point. Evidently many were stalled or plain kneecapped in the US by lack of enrollees reacting to the hysteria.

notable: Costa Rica to resume use of hydroxychloroquine for COVID-19 treatment National CFR of 0.75% and only 5% of actives needing hospitalization? "Needs more research" What are they testing, boner pills? ...while this is the fruit of scaremongering and politicization in a health care crisis: think anyone will pity us when this is all said and done?

Interested to see what this Catalan study is all about after review: Coronavirus - "Out of 150 drugs tested, two worked a little better: remdesivir and chloroquine" translation (wording not perfect):