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triplehorn

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Posts posted by triplehorn

  1. 5 minutes ago, Dahobbs said:

    There is no demonstrated benefit to hcq for treatment of covid-19.

    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."

     

    Quote

    Hydroxychloroquine+azithromycin has been widely misrepresented in both clinical reports and public media, and outpatient trials results are not expected until September. Early outpatient illness is very different than later hospitalized florid disease and the treatments differ. Evidence about use of hydroxychloroquine alone, or of hydroxychloroquine+azithromycin in inpatients, is irrelevant concerning efficacy of the pair in early high-risk outpatient disease. Five studies, including two controlled clinical trials, have demonstrated significant major outpatient treatment efficacy. Hydroxychloroquine+azithromycin has been used as standard-of-care in more than 300,000 older adults with multicomorbidities, with estimated proportion diagnosed with cardiac arrhythmias attributable to the medications 47/100,000 users, of which estimated mortality is <20%, 9/100,000 users, compared to the 10,000 Americans now dying each week. These medications need to be widely available and promoted immediately for physicians to prescribe.

     

     

  2. 7 minutes ago, Dahobbs said:

    If you live in California or Utah or Minnesota, or pretty much anywhere in the US, a doctor would be committing malpractice by prescribing you HCQ to prevent or treat malaria. There is no threat of encountering malaria. Here is the label:

    A doctor shouldn't be prescribing HCQ unless the person is likely to be exposed to malaria, has been exposed malaria, or currently has uncomplicated malaria. 

    Stop with your nonsense. 

    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.

     

     

  3. 2 minutes ago, Dahobbs said:

    Dear god, no. An Emergency Use Authorization removes regulatory red tape from the manufacturers and distributors of medical products.  Basically, it allows the manufacturers and distributors of the an unapproved product (in this case, oral formulations of HCQ and CQ) to distribute the product to the public. It also allows manufacturers and distributors to distribute an approved product for an unapproved use (in this case, distributing HCQ and CQ for use to treat Covid-19), including making changes to their labeling and advertising without going through the typical regulatory process with the FDA. 

    In this particular instance, the EUA was specifically aimed at allow the Strategic National Stockpile to distribute oral formulations of HCQ and CQ to the public for use in treating Covid-19. Revocation of the EUA means the SNS cannot continue to distribute product for that purpose (and neither can private entities). 

    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.

     

    7 minutes ago, Dahobbs said:

     HCQ is considered safe and effective for treating certain conditions, mainly malaria, but also some forms of lupus and arthritis. That is because despite the known complications associated of HCQ, its benefits in treating those conditions outweighs those risks.

    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.

  4. 52 minutes ago, Aqua Buddha said:

    Can someone help me with the HCQ truthers?  I have a friend that is convinced HCQ is working around the world but we refuse to use it because of some grand conspiracy.  Is it working worldwide?  Thanks, I'll hang up and listen.

    Re-linking this PDF from bottom of last page.  There's quite a lot out there.

     

     

    13 minutes ago, JBJ said:

    It's too dangerous to use in the quantities required to be an effective treament.

    How do you derive this assertion?

  5. 1 hour ago, trauma babe said:

    Given the choice between HCQ and decadron...I'll take the decadron

    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.

  6. 30 minutes ago, Dahobbs said:

     

    "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

     

     

     

     

  7. 1 hour ago, GRHorn said:

    Gonna have to take a wait and see approach after the HCQ fiasco 

    Re dexamethasone, great news if true. 

    Another old generic repurposed drug from the 50's?  If only they turned profits for big pharma.

    • Like 1
  8. 29 minutes ago, Dahobbs said:

    Seriously, what is your malfunction? From the actual letter:

    Stop peddling this nonsense. It is malpractice for a doctor to prescribe or recommend treatment where the risks outweigh the benefits. That is where HCQ stands in relationship to Covid-19. 

    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.

  9. 12 hours ago, mdmost said:

    So maybe not the best thing to tell everyone to go out and take.

     

     

    7 hours ago, HenryJames said:

     

     

    [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.

     

  10. 47 minutes ago, VRHorn said:

    Sure, but if both of them stopped posting about it...

    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.  

  11. 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.

     

    Quote

    EaV9zS4XQAA6j7d?format=png&name=900x900

    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.  

     

  12. 16 hours ago, Anastasis said:

    I watched spies like us a few times. Does that count. 
     

    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.

     

    fletch-reboot.jpg

  13. 7 hours ago, Anastasis said:

    Wrap yourself up in a cloak of clinical mysticism if it makes you feel better, but the reality is that there is no strong evidence supporting use of HCQ as a COVID treatment in any phase of the illness. To the extent that we have solid evidence, the results are negative. The gaps in knowledge will not be filled with mystical thinking on the unknowable granularity of clinical decision making. They will be filled by clinical research. That is the only role for HCQ at the moment, use in trials addressing the remaining gaps in knowledge. Anything else is simply quackery at this point. 

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

  14. @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.

  15. 32 minutes ago, Anastasis said:

    Approaching word salad my head shrinking friend.

    I am actually totally in favor of exploring ivermectin as a therapy.  Better use of resources at this point than chasing HCQ delusions. 

    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.  

  16. 16 minutes ago, Anastasis said:

      If you want to fret about something related to COVID related research, you should fret about the time, energy and resources that have been wasted chasing the HCQ ghost based on that whacked out french data.  Those resources could have been better spent on other avenues of inquiry. 

    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:

     

     

  17. 1 hour ago, Anastasis said:

    Please point out all the RCT data coming out of Costa Rica, India, or whatever third world country that supports your argument. 

    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.

  18. 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.

     

     

  19. 18 minutes ago, Anastasis said:

    The post-exposure prophy one.  Talking about post-hoc power analysis is nonsensical in this setting.  Power is a function of sample size and effect size.  The effect size associated with HCQ is apparently extremely small in PEprophy setting (v=0.03).  Yes, you can overpower your study to detect a very small and clinically insignificant effect. That is math, but it misses the point entirely.  The effect sizes suggested early on for HCQ have simply not materialized. These are arguments intended to mislead people who don't understand the concepts being discussed.  

    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!”

     

  20. 15 minutes ago, Anastasis said:

    I pity people who tweet post hoc power analyses in the context of a sample size discussion for a prospective interventional trial. 

    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.

  21. notable:  Costa Rica to resume use of hydroxychloroquine for COVID-19 treatment

    Quote

    Costa Rican health authorities said Monday that the country plans to resume its use of hydroxychloroquine to treat coronavirus patients.

    The announcement came from Román Macaya, the executive president of the Costa Rican Social Security System (CCSS), even as he acknowledged the drug’s efficacy against COVID-19 has not yet been proven.

    “Efficacy is something we have to answer with a clinical study,” Macaya said.

    The CCSS had temporarily stopped using hydroxychloroquine for COVID-19 in late May after a study published in The Lancet prompted the World Health Organization (WHO) to do the same.

    That study — which indicated that using the drug on hospitalized coronavirus patients could increase their chances of dying — has since come under independent criticism, and the WHO has resumed its own hydroxychloroquine study.

    In Costa Rica, all patients — including those with minor symptoms or who are asymptomatic — are offered the option to take hydroxychloroquine upon their diagnosis, as long as they don’t have contraindications to the drug, Macaya said.

    The country has provided the drug to coronavirus patients since conferencing with Chinese experts in April, according to Mario Ruíz, Medical Manager of the CCSS.

    Costa Rica has a low case fatality rate (.75%), and fewer than 5% of known active coronavirus cases are currently hospitalized.

    “We can’t say that’s a result of this medication, but we can’t discard it either,” Macaya said last month. The CCSS has not released data comparing the outcomes of patients treated with hydroxychloroquine to other methods.

    On Monday, Macaya suggested that CCSS’s commitment to daily check-in calls for everyone infected with SARS-CoV-2 has helped keep deaths low.

    The daily conversations and ongoing symptom tracking ensure that patients are hospitalized at the appropriate time, Macaya said. 

    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?

  22. 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):

    Quote

    The study of the scientific journal The Lancet has revived the global debate around the use of hydroxychloroquine against Covid-19.

    Study which indicated that hydroxychloroquine had no effect on the disease and especially that it presented dangers for the patients. The World Health Organization (WHO) had then suspended clinical trials with hydroxychloroquine before reversing, following revelations concerning the data provided to the doctors authoring the study. 

    For Oriol Mitjà, expert in infectious diseases at the Germans Trias i Pujol Research Institute in Badalone, near Barcelona, the error "does not come from The Lancet, but from the authors of the study and especially the data". According to the Catalan, interviewed by TV3 , "these data were too perfect to be credible".

    It is the work of "Australian researchers" who have highlighted the shortcomings of this study. "They saw that the data did not match".

    Catalan study soon to be published

    Elected Catalan of the Year in 2018, Oriol Mitjà himself is conducting a clinical trial on hydroxychloroquine, the results of which should be published soon. "The study is already finished and the conclusions await an external examination, precisely so that the results have all the guarantees," say our colleagues from Catalan television.

    Without advancing on the results of his study Oriol Mitjà already finds that "of all the drugs tested in the laboratory (more than 150), only two worked a little better: remdesivir and chloroquine. Many people in our country have been treated with chloroquine. "

     

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